Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K092648 |
Device Name |
RESPIRONICS PERFORMAX SE TOTAL FACE MASK |
Applicant |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
1740 GOLDEN MILE HWY |
MONROEVILLE,
PA
15146
|
|
Applicant Contact |
ZITA A YURKO |
Correspondent |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
1740 GOLDEN MILE HWY |
MONROEVILLE,
PA
15146
|
|
Correspondent Contact |
ZITA A YURKO |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 08/28/2009 |
Decision Date | 12/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|