Device Classification Name |
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
|
510(k) Number |
K923433 |
Device Name |
AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE |
Applicant |
INSTRUMENTARIUM CORP. |
TEOLLISUUSKATU 27 |
00510 HELSINKI 51 |
FINLAND,
FI
|
|
Applicant Contact |
SEPPO LUODE |
Correspondent |
INSTRUMENTARIUM CORP. |
TEOLLISUUSKATU 27 |
00510 HELSINKI 51 |
FINLAND,
FI
|
|
Correspondent Contact |
SEPPO LUODE |
Regulation Number | 868.1500
|
Classification Product Code |
|
Date Received | 07/13/1992 |
Decision Date | 07/22/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|