SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.

Computer, Blood-pressure

SPECTRAMED, INC.

The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Safe-draw(tm) Blood Sampling Reservoir & Access..

Pre-market Notification Details

Device IDK885235
510k NumberK885235
Device Name:SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
ClassificationComputer, Blood-pressure
Applicant SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
ContactRobert L Leavitt
CorrespondentRobert L Leavitt
SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
Product CodeDSK  
CFR Regulation Number870.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-20
Decision Date1989-01-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884450372535 K885235 000

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