ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT

Blood Pressure Cuff

STATCORP MEDICAL

The following data is part of a premarket notification filed by Statcorp Medical with the FDA for Ultracheck Spacelabs Abp Cuff-child, Ultracheck Spacelabs Abp Cuff-small Adult, Ultracheck Spacelabs Abp Cuff-adult, Ultracheck Spacelabs Abp Cuff-large Adult.

Pre-market Notification Details

Device IDK152801
510k NumberK152801
Device Name:ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT
ClassificationBlood Pressure Cuff
Applicant STATCORP MEDICAL 14476 Duval Place West Suite 303 Jacksonville,  FL  32218
ContactWayne Emmert
CorrespondentWayne Emmert
STATCORP MEDICAL 14476 Duval Place West Suite 303 Jacksonville,  FL  32218
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-28
Decision Date2015-10-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522102639 K152801 000
10841522102615 K152801 000
10841522102561 K152801 000
10841522102660 K152801 000
10841522128530 K152801 000
10841522128523 K152801 000
10841522128516 K152801 000
10841522128509 K152801 000

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