PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T

Oximeter

PHILIPS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Spo2 Reusable Sensors, Model Nos. M1191t, M1192t, And M1193t.

Pre-market Notification Details

Device IDK032979
510k NumberK032979
Device Name:PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
ClassificationOximeter
Applicant PHILIPS MEDICAL SYSTEMS, INC. HEWLETT PACKARD STR. 2 Boblingen,  DE D71034
ContactEgon Pfeil
CorrespondentEgon Pfeil
PHILIPS MEDICAL SYSTEMS, INC. HEWLETT PACKARD STR. 2 Boblingen,  DE D71034
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-24
Decision Date2004-02-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838011946 K032979 000
00884838010277 K032979 000
00884838010253 K032979 000
00884838010239 K032979 000

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