BLOOD PRESSURE CUFF 1

Blood Pressure Cuff

PEDIA PALS, INC.

The following data is part of a premarket notification filed by Pedia Pals, Inc. with the FDA for Blood Pressure Cuff 1.

Pre-market Notification Details

Device IDK951039
510k NumberK951039
Device Name:BLOOD PRESSURE CUFF 1
ClassificationBlood Pressure Cuff
Applicant PEDIA PALS, INC. 3939 INTERNATIONAL GATEWAY Columbus,  OH  43219
ContactDavid L Barnes
CorrespondentDavid L Barnes
PEDIA PALS, INC. 3939 INTERNATIONAL GATEWAY Columbus,  OH  43219
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-06
Decision Date1995-10-31

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