CUFF, BLOOD PRESSURE

Blood Pressure Cuff

BUFFALO MEDICAL SPECIALTIES MFG., INC.

The following data is part of a premarket notification filed by Buffalo Medical Specialties Mfg., Inc. with the FDA for Cuff, Blood Pressure.

Pre-market Notification Details

Device IDK902132
510k NumberK902132
Device Name:CUFF, BLOOD PRESSURE
ClassificationBlood Pressure Cuff
Applicant BUFFALO MEDICAL SPECIALTIES MFG., INC. P.O. BOX 17247 14205 MYER LAKE CIRCLE Clearwater,  FL  33520
ContactO. Q Hansen
CorrespondentO. Q Hansen
BUFFALO MEDICAL SPECIALTIES MFG., INC. P.O. BOX 17247 14205 MYER LAKE CIRCLE Clearwater,  FL  33520
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-10
Decision Date1990-06-29

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