Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K102054 |
Device Name |
V200 VENTILATOR |
Applicant |
RESPIRONICS CALIFORNIA, INC. |
2271 COSMOS CT. |
CARLSBAD,
CA
92011
|
|
Applicant Contact |
TAMATHA LEY |
Correspondent |
RESPIRONICS CALIFORNIA, INC. |
2271 COSMOS CT. |
CARLSBAD,
CA
92011
|
|
Correspondent Contact |
TAMATHA LEY |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 07/22/2010 |
Decision Date | 12/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|