Device Classification Name |
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
|
510(k) Number |
K914295 |
Device Name |
ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED |
Applicant |
BRUEL & KJAER |
18 NAERUM HOVEDGODE |
NAERUM 2850,
DK
|
|
Applicant Contact |
AAGE RUBY |
Correspondent |
BRUEL & KJAER |
18 NAERUM HOVEDGODE |
NAERUM 2850,
DK
|
|
Correspondent Contact |
AAGE RUBY |
Regulation Number | 868.1500
|
Classification Product Code |
|
Date Received | 09/09/1991 |
Decision Date | 04/10/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|