Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K120145 |
Device Name |
SIMPLE T NASAL MASK |
Applicant |
RESPIRONICS INC. |
1001 MURRY RIDGE LANE |
MURRYSVILLE,
PA
15668
|
|
Applicant Contact |
MICHELLE BRINKER |
Correspondent |
RESPIRONICS INC. |
1001 MURRY RIDGE LANE |
MURRYSVILLE,
PA
15668
|
|
Correspondent Contact |
MICHELLE BRINKER |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 01/18/2012 |
Decision Date | 03/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|