Device Classification Name |
Oximeter
|
510(k) Number |
K970061 |
Device Name |
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) |
Applicant |
DATASCOPE CORP. |
580 WINTERS AVE. |
PARAMUS,
NJ
07653
|
|
Applicant Contact |
FRANK CASAMSSINA |
Correspondent |
DATASCOPE CORP. |
580 WINTERS AVE. |
PARAMUS,
NJ
07653
|
|
Correspondent Contact |
FRANK CASAMSSINA |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 01/07/1997 |
Decision Date | 09/25/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|