PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL

Oximeter

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Adult Reusable Sp02 Sensor, Model M1191b, M1191bl, M1191bnl.

Pre-market Notification Details

Device IDK062455
510k NumberK062455
Device Name:PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL
ClassificationOximeter
Applicant PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
ContactRich Mccleary
CorrespondentRich Mccleary
PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-23
Decision Date2006-11-03
Summary:summary

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