Device Classification Name |
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
|
510(k) Number |
K943458 |
Device Name |
AS/3 AIRWAY MODULE |
Applicant |
DATEX DIVISION INSTRUMENTARIUM CORP. |
27 TEOLLISUUSKATU |
HELSINKI,
FI
|
|
Applicant Contact |
VINCENT RAUSCHER |
Correspondent |
DATEX DIVISION INSTRUMENTARIUM CORP. |
27 TEOLLISUUSKATU |
HELSINKI,
FI
|
|
Correspondent Contact |
VINCENT RAUSCHER |
Regulation Number | 868.1620
|
Classification Product Code |
|
Date Received | 07/18/1994 |
Decision Date | 02/14/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|