Device Classification Name |
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
|
510(k) Number |
K903104 |
Device Name |
CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR |
Applicant |
DATEX DIVISION INSTRUMENTARIUM CORP. |
P.O. BOX 446 |
SF-00101 |
HELSINKI, FINLAND,
FI
|
|
Applicant Contact |
OLLI RIIKKALA |
Correspondent |
DATEX DIVISION INSTRUMENTARIUM CORP. |
P.O. BOX 446 |
SF-00101 |
HELSINKI, FINLAND,
FI
|
|
Correspondent Contact |
OLLI RIIKKALA |
Regulation Number | 868.1500
|
Classification Product Code |
|
Date Received | 07/13/1990 |
Decision Date | 01/23/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|