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CADWELL ARC APOLLO EEG SYSTEM - HSA Registration DE0504071

Access comprehensive regulatory information for CADWELL ARC APOLLO EEG 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 DE0504071 and owned by Cadwell Industries, Inc.. The device was registered on January 28, 2020.

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
DE0504071
CADWELL ARC APOLLO EEG SYSTEM
HSA Registration Number: DE0504071
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Product Description

The Cadwell Apollo system is indicated for prescription use to acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic1 (PSG) ambulatory and/or clinical studies of patients of all ages.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0504071
Registration Date
January 28, 2020
Retention Due Date
January 27, 2026
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)
ARC PHOTIC STIMULATOR Q-VIDEO MOBILE 3 RECORDER ARC Apollo Amplifer ARC Apollo Amplifer APOLLO RECORDER CADWELL PATIENT EVENT SWITCH ARC SOFTWARE DESK ARC SOFTWARE USB
Model Identifier(s)
190289-200 190298-200 190301-200 190302-200 190304-200 199244-200 369045-200 369045-201