Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K032834 |
Device Name |
BIPAP PRO 2 BI-LEVEL SYSTEM |
Applicant |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Applicant Contact |
ZITA A YURKO |
Correspondent |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Correspondent Contact |
ZITA A YURKO |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 09/11/2003 |
Decision Date | 03/04/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|