Device Classification Name |
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
|
510(k) Number |
K926451 |
Device Name |
DATASCOPE MULTINEX II |
Applicant |
DATASCOPE CORP. |
580 WINTERS AVE. |
P.O. BOX 5 |
PARAMUS,
NJ
07653
|
|
Applicant Contact |
MICHAEL BARILE |
Correspondent |
DATASCOPE CORP. |
580 WINTERS AVE. |
P.O. BOX 5 |
PARAMUS,
NJ
07653
|
|
Correspondent Contact |
MICHAEL BARILE |
Regulation Number | 868.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/24/1992 |
Decision Date | 08/25/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|