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
|
|
Correspondent Contact |
WAYNE EMMERT |
Regulation Number | 870.1120
|
Classification Product Code |
|
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
|