Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K150638 |
FOIA Releasable 510(k) |
K150638
|
Device Name |
AF541 SE Full Face Mask |
Applicant |
Respironics, Inc. |
1001 Murry Ridge Lane |
Murrysville,
PA
15668
|
|
Applicant Contact |
Shaylee Masilunas |
Correspondent |
Respironics, Inc. |
1001 Murry Ridge Lane |
Murrysville,
PA
15668
|
|
Correspondent Contact |
Shaylee Masilunas |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 03/11/2015 |
Decision Date | 09/18/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|