Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K142554 |
Device Name |
Revolution Full Face Mask |
Applicant |
Respironics, Inc. |
1001 Murry Ridge Lane |
Murrysville,
PA
15668
|
|
Applicant Contact |
Amy Macevoy |
Correspondent |
Respironics, Inc. |
1001 Murry Ridge Lane |
Murrysville,
PA
15668
|
|
Correspondent Contact |
Amy Macevoy |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 09/11/2014 |
Decision Date | 01/09/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|