Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K954632 |
Device Name |
SIEMENS SC 9000 ETCO2 MODULE |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. |
DANVERS,
MA
01923
|
|
Applicant Contact |
THOMAS CONNELLY |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. |
DANVERS,
MA
01923
|
|
Correspondent Contact |
THOMAS CONNELLY |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 10/06/1995 |
Decision Date | 02/05/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|