Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K072588 |
Device Name |
PERFORMAX SE TOTAL FACE MASK |
Applicant |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Applicant Contact |
ZITA YURKO |
Correspondent |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Correspondent Contact |
ZITA YURKO |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 09/14/2007 |
Decision Date | 12/18/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|