SERUM BICARBONATE/CARBON DIOXIDE

Enzymatic, Carbon-dioxide

DATA MEDICAL ASSOCIATES, INC.

The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Serum Bicarbonate/carbon Dioxide.

Pre-market Notification Details

Device IDK955302
510k NumberK955302
Device Name:SERUM BICARBONATE/CARBON DIOXIDE
ClassificationEnzymatic, Carbon-dioxide
Applicant DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
ContactC.h. Morris
CorrespondentC.h. Morris
DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
Product CodeKHS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-20
Decision Date1996-02-29

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