Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K001315 |
Device Name |
MODIFICATION TO KION ANESTHESIA SYSTEM |
Applicant |
SIEMENS ELEMA AB |
ELECTROMEDICAL SYSTEMS GROUP |
16 ELECTRONICS AVENUE |
DANVERS,
MA
01923
|
|
Applicant Contact |
DAVE SIMARD |
Correspondent |
SIEMENS ELEMA AB |
ELECTROMEDICAL SYSTEMS GROUP |
16 ELECTRONICS AVENUE |
DANVERS,
MA
01923
|
|
Correspondent Contact |
DAVE SIMARD |
Regulation Number | 868.5160
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/26/2000 |
Decision Date | 05/26/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|