Device Classification Name |
computer, blood-pressure
|
510(k) Number |
K011865 |
Device Name |
ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION |
Applicant |
ZOLL MEDICAL CORP. |
32 SECOND AVE. |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
PAUL DIAS |
Correspondent |
ZOLL MEDICAL CORP. |
32 SECOND AVE. |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
PAUL DIAS |
Regulation Number | 870.1110
|
Classification Product Code |
|
Date Received | 06/14/2001 |
Decision Date | 07/31/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|