CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER

System, Measurement, Blood-pressure, Non-invasive

DYNATECH/NEVADA, INC.

The following data is part of a premarket notification filed by Dynatech/nevada, Inc. with the FDA for Cufflink Non-invasive Blood Pressure Analyzer.

Pre-market Notification Details

Device IDK942546
510k NumberK942546
Device Name:CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant DYNATECH/NEVADA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington,  DC  20004 -1109
ContactHoward M Holstein
CorrespondentHoward M Holstein
DYNATECH/NEVADA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington,  DC  20004 -1109
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-31
Decision Date1995-01-27

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