Device Classification Name |
analyzer, gas, enflurane, gaseous-phase (anesthetic concentration)
|
510(k) Number |
K883532 |
Device Name |
ICOR AGENT MONITOR |
Applicant |
ICOR AB |
ULVSUNDAVAGEN 178 B |
BROMMA,
SE
161 30
|
|
Applicant Contact |
GEDEON, PHD |
Correspondent |
ICOR AB |
ULVSUNDAVAGEN 178 B |
BROMMA,
SE
161 30
|
|
Correspondent Contact |
GEDEON, PHD |
Regulation Number | 868.1500
|
Classification Product Code |
|
Date Received | 08/18/1988 |
Decision Date | 11/04/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|