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NONIN Model 3150 WristOx2 Pulse Oximeter - HSA Registration DE0503352

Access comprehensive regulatory information for NONIN Model 3150 WristOx2 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 DE0503352 and owned by Nonin Medical, Inc.. The device was registered on July 12, 2019.

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
DE0503352
NONIN Model 3150 WristOx2 Pulse Oximeter
HSA Registration Number: DE0503352
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Product Description

The Nonin Model 3150 Wrist Ox2TM pulse oximeter is a small, wrist-worn device indicated for use is measuring, displaying and sorting functional oxygen saturation of arterial haemoglobin (spO2) and pulse rate. It may be used for spot-checking and/or data collection and recording of adult and pediatric patients during both no motion and motion conditions and for patients who are well or poorly perfused. The intended use environments are hospitals, medical facilities, ambulatory, subacute, sleep study environments and mobile units.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0503352
Registration Date
July 12, 2019
Retention Due Date
July 11, 2025
Product Owner
Short Name
Nonin Medical, Inc.
Address
13700 1st Avenue North,, Plymouth MN 55441-5443, 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 3150 WRIST-OX2, USB Model 3150I 16 to 9 position cable MODEL 3150SC WRIST-OX2 USB COMMUNICATION CABLE Model 3150(SK) STARTER KIT, USB MODEL 3150WB-REUSABLE OR DISPOSABLE WRISTBANDS MODEL 3150WI WRIST-OX2 SENSOR INTERFACE CABLE Adult Disposable Single-Patient UsePulse Oximeter Sensor Pediatric Disposable Single-Patient Use Pulse Oximeter Sensor Model 6500MA Adult sensor disposable Model 6500SA Adult sensor disposable Flexi-Form® III disposable sensor; adult, disposable Flexi-Form® III disposable sensor; Pediatric , disposable Model 8000AA Adult Articulated Finger Clip Sensor MODEL 8000AA-WO2 WRIST OX 2 FINGER CLIP SENSOR Model 8000AP Pediatric Finger Clip Sensor Model 8000H Reflectance sensor holder Model 8000J Adult Flex sensor MODEL 8000J-WO2 ADULT FLEX SENSOR Model 8000JFW Adult Flexiwrap sensor Model 8000Q2 Ear clip sensor Model 8000R Reflectance sensor Model 8000SL Soft sensor large 1m MODEL 8000SL-WO2 Model 8000SM Soft sensor medium 1m MODEL 8000SM-WO2 Model 8000SS Soft sensor small 1m MODEL 8000SS-WO2 nVISION®
Model Identifier(s)
3150 3150I 3150SC 3150SK 3150WB 3150WI 6000CA 6000CP 6500MA 6500SA 7000A 7000P 8000AA 8000AA-WO2 8000AP 8000H 8000J 8000J-WO2 8000JFW 8000Q2 8000R 8000SL 8000SL-WO2 8000SM 8000SM-WO2 8000SS 8000SS-WO2 nVISION® Data Management Software