Device Classification Name |
ventilator, continuous, minimal ventilatory support, facility use
|
510(k) Number |
K951264 |
Device Name |
BIPAP MODEL S/T-D |
Applicant |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Applicant Contact |
DENNIS S METENY |
Correspondent |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Correspondent Contact |
DENNIS S METENY |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 03/21/1995 |
Decision Date | 07/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|