Device Classification Name |
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
|
510(k) Number |
K082660 |
Device Name |
V60 VENTILATOR, MODEL V8000 |
Applicant |
RESPIRONICS CALIFORNIA, INC. |
2271 COSMOS CT. |
CARLSBAD,
CA
92011
|
|
Applicant Contact |
MARA CALER |
Correspondent |
RESPIRONICS CALIFORNIA, INC. |
2271 COSMOS CT. |
CARLSBAD,
CA
92011
|
|
Correspondent Contact |
MARA CALER |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 09/12/2008 |
Decision Date | 01/09/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|