Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K130077 |
FOIA Releasable 510(k) |
K130077
|
Device Name |
REMSTAR SE |
Applicant |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Applicant Contact |
FRANK KADI |
Correspondent |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Correspondent Contact |
FRANK KADI |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 01/14/2013 |
Decision Date | 05/21/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|