Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K981971 |
Device Name |
TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3 |
Applicant |
BIRD PRODUCTS CORP. |
1100 BIRD CENTER DR. |
PALM SPRINGS,
CA
92262
|
|
Applicant Contact |
NEIL BATTISTE |
Correspondent |
BIRD PRODUCTS CORP. |
1100 BIRD CENTER DR. |
PALM SPRINGS,
CA
92262
|
|
Correspondent Contact |
NEIL BATTISTE |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 06/04/1998 |
Decision Date | 08/24/1998 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|