ULTRACHECK CURVE BLOOD PRESSURE CUFFS


Device Classification Name

antimicrobial blood pressure cuff

510(k) Number K122365
Device Name ULTRACHECK CURVE BLOOD PRESSURE CUFFS
Applicant
STATCORP MEDICAL
14476 duval pl w ste 303
jacksonville, 
FL 
32218

Applicant Contact wayne emmert
Correspondent
STATCORP MEDICAL
14476 duval pl w ste 303
jacksonville, 
FL 
32218

Correspodent Contact wayne emmert
Regulation Number 870.1120
Classification Product Code
OED  
Date Received 08/06/2012
Decision Date 06/04/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No