Device Classification Name |
Computer, Diagnostic, Pre-Programmed, Single-Function
|
510(k) Number |
K880301 |
Device Name |
3000 PHYSIOLOGICAL MONITOR |
Applicant |
DATASCOPE CORP. |
580 WINTERS AVE. |
P.O. BOX 5 |
PARAMUS,
NJ
07653
|
|
Applicant Contact |
ARTHUR FRIEDMAN |
Correspondent |
DATASCOPE CORP. |
580 WINTERS AVE. |
P.O. BOX 5 |
PARAMUS,
NJ
07653
|
|
Correspondent Contact |
ARTHUR FRIEDMAN |
Regulation Number | 870.1435
|
Classification Product Code |
|
Date Received | 01/25/1988 |
Decision Date | 08/19/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|