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Cadwell Sierra Summit Electroneurodiagnostic System - HSA Registration DE0018366

Access comprehensive regulatory information for Cadwell Sierra Summit Electroneurodiagnostic System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018366 and owned by Cadwell Industries, Inc.. The device was registered on July 15, 2016.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0018366
Cadwell Sierra Summit Electroneurodiagnostic System
HSA Registration Number: DE0018366
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Product Description

Sierra Summit measures and displays the electrical signals generated by peripheral nerve, muscle and central nervous system. The system acquires the data necessary to perform - electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potentials (EP, brainstem, visual, somatosensory), and repetitive nerve stimulation (RNS) testing. It is intended for use only during the duration of the procedure. Indications for use include: • Measurement of sensory and motor conduction latencies and velocities including those of the peripheral nerves, spinal cord, and central nervous system • Related measurements include F-wave, H-reflex and Blink response tests, and repetitive stimulation studies • Measurement of EP amplitudes and latencies generated by electrical, auditory, and visual stimulators • Evaluation of muscle and nerve integrity by needle electromyographic examination • Evaluation of nerve, spinal cord, and cortical functionality and integrity

Device Classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0018366
Registration Date
July 15, 2016
Retention Due Date
July 14, 2025
Product Owner
Short Name
Cadwell Industries, Inc.
Address
909 N Kellogg St, Kennewick WA 99336, U.S.A., Washington, UNITED STATES
Registrant
Address
50 SERANGOON NORTH AVENUE 4, FIRST CENTRE, #05-14, SINGAPORE 555856
Importer
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #07-21, SINGAPORE 159471
Model Information
Model Name(s)
Sierra Summit Base Unit StimTroller Plus, Stirn Summit Amplifier, 2-Channel Sierra Summit Amplifier, 12 Channel, Sierra Summit Tendon Hammer Summit VEP Monitor Sensor Input Box, Remote, Top Entry 12 Ch Footswitch Headphone, HDA280 Sennheiser Auditory Stim Test Fixture Amp. Shortin/Lo-Temp Test Array Test Array, 2 CH Summit Amplifier Bone Transducer Goggles VEP LED W/Mold Enc Summit Test Array, 12 Ch Remote Input - Summit Temperature Probe Lead wire for Concentric Needle Disposable Detachable Concentric Needle Disposable Detachable Concentric Needle Disposable Detachable Concentric Needle Disposable Detachable Concentric Needle Disposable Detachable Concentric Needle Disposable Injectable Needle Electrode with lead Disposable Injectable Needle Electrode with lead Disposable Injectable Needle Electrode with lead Disposable Injectable Needle Electrode with lead Disposable Injectable Needle Electrode with lead Disposable Injectable Needle Electrode with lead Disposable Subdermal Needle Electrodes Disposable Subdermal Needle Electrodes Disposable Subdermal Needle Electrodes Twisted Pair Subdermal Needles Twisted Pair Subdermal Needles Twisted Pair Subdermal Needles Insert Earphone 10-ohm kit Software, Summit-Ascent System
Model Identifier(s)
190272-200 190274-200 190276-200 190280-200 190282-200 190283-200 190285-200 190286-200 199268-200 199272-200 199273-200 199274-200 199276-000 199277-200 199279-200 202600-000 202845-000 202846-000 202847-000 202848-000 202849-000 202850-000 202880-000 202881-000 202882-000 202883-000 202884-000 202885-000 302353-000-060 302353-000-080 302353-000-100 302820-000-060 302820-000-080 302820-000-100 359020-000 369043-200