Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K120562 |
FOIA Releasable 510(k) |
K120562
|
Device Name |
PERFORMAX PEDIATRIC EE 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 | 868.5905
|
Classification Product Code |
|
Date Received | 02/24/2012 |
Decision Date | 07/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|