Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K802459 |
Device Name |
SIEMENS-ELEMA AB CO2 MONITOR 130 |
Applicant |
SIEMENS ELEMA AB |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SIEMENS ELEMA AB |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 10/08/1980 |
Decision Date | 10/23/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|