Device Classification Name |
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
|
510(k) Number |
K902276 |
Device Name |
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.) |
Applicant |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Applicant Contact |
EUGENE N SCARBERRY |
Correspondent |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Correspondent Contact |
EUGENE N SCARBERRY |
Regulation Number | 868.2600
|
Classification Product Code |
|
Date Received | 05/21/1990 |
Decision Date | 08/17/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|