Device Classification Name |
blood pressure cuff
|
510(k) Number |
K962655 |
Device Name |
ANEROID AND MERCURIAL SPHYGMOMANOMETERS |
Applicant |
AMERICAN DIAGNOSTIC CORP. |
93 OTIS ST. |
WEST BABYLON,
NY
11704
|
|
Applicant Contact |
MARC BLITSTEIN |
Correspondent |
AMERICAN DIAGNOSTIC CORP. |
93 OTIS ST. |
WEST BABYLON,
NY
11704
|
|
Correspondent Contact |
MARC BLITSTEIN |
Regulation Number | 870.1120
|
Classification Product Code |
|
Date Received | 07/08/1996 |
Decision Date | 01/27/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|