ANTIMICROBIAL AND SINGLE-PATIENT CUFFS

Antimicrobial Blood Pressure Cuff

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Antimicrobial And Single-patient Cuffs.

Pre-market Notification Details

Device IDK071885
510k NumberK071885
Device Name:ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
ClassificationAntimicrobial Blood Pressure Cuff
Applicant PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
ContactPeter Schipelliti
CorrespondentPeter Schipelliti
PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
Product CodeOED  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-09
Decision Date2007-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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20884838037568 K071885 000
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20884838002993 K071885 000

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