Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K120639 |
Device Name |
PERFORMAX PEDIATRIC SE TOTAL FACE MASK |
Applicant |
RESPIRONICS, INC. |
365 PLUM INDUSTRIAL COURT |
PITTSBURGH,
PA
15239
|
|
Applicant Contact |
MICHELLE BRINKER |
Correspondent |
RESPIRONICS, INC. |
365 PLUM INDUSTRIAL COURT |
PITTSBURGH,
PA
15239
|
|
Correspondent Contact |
MICHELLE BRINKER |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 03/02/2012 |
Decision Date | 07/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|