MODEL OX-1 OXYGEN SATURATION MODULE

Oximeter

COLIN MEDICAL INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Model Ox-1 Oxygen Saturation Module.

Pre-market Notification Details

Device IDK884822
510k NumberK884822
Device Name:MODEL OX-1 OXYGEN SATURATION MODULE
ClassificationOximeter
Applicant COLIN MEDICAL INSTRUMENTS CORP. 107G CORPORATE BLVD. South Plainfield,  NJ  07080
ContactAlan P Schwartz
CorrespondentAlan P Schwartz
COLIN MEDICAL INSTRUMENTS CORP. 107G CORPORATE BLVD. South Plainfield,  NJ  07080
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-18
Decision Date1989-03-02

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