PICOSAT II SPO2 PULSE OXIMETRY MODULE

Oximeter

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Picosat Ii Spo2 Pulse Oximetry Module.

Pre-market Notification Details

Device IDK030973
510k NumberK030973
Device Name:PICOSAT II SPO2 PULSE OXIMETRY MODULE
ClassificationOximeter
Applicant PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
ContactDavid Osborn
CorrespondentDavid Osborn
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 Received2003-03-28
Decision Date2003-07-23
Summary:summary

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