Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K970839 |
Device Name |
SERVO VENTILATOR 300A |
Applicant |
SIEMENS ELEMA AB |
RONTGENVAGEN 2 |
S-17195 SOLNA,
SE
|
|
Applicant Contact |
ANN-CHRISTINE JONSSON |
Correspondent |
SIEMENS ELEMA AB |
RONTGENVAGEN 2 |
S-17195 SOLNA,
SE
|
|
Correspondent Contact |
ANN-CHRISTINE JONSSON |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 03/07/1997 |
Decision Date | 10/14/1997 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|