Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K140980 |
FOIA Releasable 510(k) |
K140980
|
Device Name |
TI NASAL MASK |
Applicant |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Applicant Contact |
SHAYLEE MASILUNAS |
Correspondent |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Correspondent Contact |
SHAYLEE MASILUNAS |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 04/16/2014 |
Decision Date | 02/10/2015 |
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
|
|
|