Device Classification Name |
gas, calibration (specified concentration)
|
510(k) Number |
K863675 |
Device Name |
CALIBRATION GAS FOR SERVO GAS MONITOR 120 |
Applicant |
SIEMENS ELEMA AB |
2360 NORTH PALMER DR. |
P.O. BOX 94517 |
SCHAUMBURG,
IL
60195
|
|
Applicant Contact |
CHRISTER HELLSTEN |
Correspondent |
SIEMENS ELEMA AB |
2360 NORTH PALMER DR. |
P.O. BOX 94517 |
SCHAUMBURG,
IL
60195
|
|
Correspondent Contact |
CHRISTER HELLSTEN |
Regulation Number | 868.6400
|
Classification Product Code |
|
Date Received | 09/19/1986 |
Decision Date | 11/03/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|