ULTRACHECK CURVE BLOOD PRESSURE CUFFS

Antimicrobial Blood Pressure Cuff

STATCORP MEDICAL

The following data is part of a premarket notification filed by Statcorp Medical with the FDA for Ultracheck Curve Blood Pressure Cuffs.

Pre-market Notification Details

Device IDK122365
510k NumberK122365
Device Name:ULTRACHECK CURVE BLOOD PRESSURE CUFFS
ClassificationAntimicrobial Blood Pressure Cuff
Applicant STATCORP MEDICAL 14476 Duval Pl W Ste 303 Jacksonville,  FL  32218
ContactWayne Emmert
CorrespondentWayne Emmert
STATCORP MEDICAL 14476 Duval Pl W Ste 303 Jacksonville,  FL  32218
Product CodeOED  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-06
Decision Date2013-06-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522106835 K122365 000
10841522106880 K122365 000
10841522106866 K122365 000

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