Device Classification Name |
Electrocardiograph
|
510(k) Number |
K860646 |
Device Name |
PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART |
Applicant |
ANALOGIC CORP. |
8 CENTENNIAL DR. |
PEABODY,
MA
01960
|
|
Applicant Contact |
MARVIN ROSENBAUM |
Correspondent |
ANALOGIC CORP. |
8 CENTENNIAL DR. |
PEABODY,
MA
01960
|
|
Correspondent Contact |
MARVIN ROSENBAUM |
Regulation Number | 870.2340 |
Classification Product Code |
|
Date Received | 02/20/1986 |
Decision Date | 10/16/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|