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Nonin® Model 2500 PalmSAT® Pulse Oximeter - HSA Registration DE0500987

Access comprehensive regulatory information for Nonin® Model 2500 PalmSAT® Pulse Oximeter in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0500987 and owned by Nonin Medical, Inc.. The device was registered on December 18, 2017.

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 C
DE0500987
Nonin® Model 2500 PalmSAT® Pulse Oximeter
HSA Registration Number: DE0500987
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Product Description

The Nonin® Model 2500 PalmSAT® Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric and neonatal patients. The device is intended for spot-checking and/or continuous monitoring of patients during motion and no-motion conditions, and for patients who are well or poorly perfused.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0500987
Registration Date
December 18, 2017
Retention Due Date
December 17, 2025
Product Owner
Short Name
Nonin Medical, Inc.
Address
13700 1st Avenue North, Plymouth, MN 55441, UNITED STATES
Registrant
Address
4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Importer
Address
4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Model Information
Model Name(s)
Model 2500 PALMSAT HANDHELD OXIMETER Model 2500A PULSE OXIMETER W/ALARMS Rechargable NiMH Battery Pack Charger Stand Model 2500C-UNIV charger stand universal Adult Disposable Single-Patient UsePulse Oximeter Sensor Infant Disposable Single-Patient Use Neonatal/Adult Disposable Single-Patient Use Pulse Oximeter Sensor Pediatric Disposable Single-Patient Use Pulse Oximeter Sensor Flexi-Form® III disposable sensor; adult Flexi-Form® III disposable sensor; infant Flexi-Form® III disposable sensor; neonatal Flexi-Form® III disposable sensor; Pediatric Power cord, United Kingdom Model 8000AA Adult Articulated Finger Clip Pulse Oximeter Sensor Model 8000AA-2 Adult Articulated Finger Clip Pulse Oximeter Sensor Model 8000AA-3 Adult Articulated Finger Clip Pulse Oximeter Sensor Model 8000AP Pediatric Finger Clip Pulse Oximeter Sensor Model 8000AP-2 Pediatric Finger Clip Pulse Oximeter Sensor Model 8000AP-3 Pediatric Finger Clip Pulse Oximeter Sensor 3m Model 8000J Reusable Adult Flex Pulse Oximeter Model 8000J-3 Reusable Adult Flex Pulse Oximeter Sensor Model 8000JFW Adult FlexiWrap Model 8000Q2 Ear clip sensor Model 8000R Reflectance sensor Model 8000SL Soft sensor large 1m Model 8000SL Soft sensor large 3m Model 8000SM Soft sensor medium 1m Model 8000SM Soft sensor medium 3m Model 8000SS Soft sensor small 1m Model 8000SS Soft sensor small 3m Model 8001J Neonatal Flex Sensor Model 8001JFW Neonate FlexiWrap Model 8008J Infant Flex Sensor Model 8008JFW Infant FlexiWrap nVISION®
Model Identifier(s)
2500 2500A 2500B 2500C 2500C-UNIV 6000CA 6000CI 6000CN 6000CP 7000A 7000I 7000N 7000P 7600PCS–UK 8000AA 8000AA-2 8000AA-3 8000AP 8000AP-2 8000AP-3 8000J 8000J-3 8000JFW 8000Q2 8000R 8000SL 8000SL-3 8000SM 8000SM-3 8000SS 8000SS-3 8001J 8001JFW 8008J 8008JFW nVISION® Data Management Software