Device Classification Name |
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
|
510(k) Number |
K974903 |
Device Name |
GAS MODULE II, MODEL 0998-00-0143 |
Applicant |
DATASCOPE CORP. |
580 WINTERS AVE. |
P.O. BOX 5 |
PARAMUS,
NJ
07653
|
|
Applicant Contact |
RUSSELL OLSEN |
Correspondent |
DATASCOPE CORP. |
580 WINTERS AVE. |
P.O. BOX 5 |
PARAMUS,
NJ
07653
|
|
Correspondent Contact |
RUSSELL OLSEN |
Regulation Number | 868.1620
|
Classification Product Code |
|
Date Received | 12/31/1997 |
Decision Date | 03/13/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|