Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K930747 |
Device Name |
BIRD 8400TI ADULT VOLUME VENTILATOR |
Applicant |
BIRD PRODUCTS CORP. |
1100 BIRD CENTER DR. |
PALM SPRINGS,
CA
92262
|
|
Applicant Contact |
WILLIAM C BENTINICK |
Correspondent |
BIRD PRODUCTS CORP. |
1100 BIRD CENTER DR. |
PALM SPRINGS,
CA
92262
|
|
Correspondent Contact |
WILLIAM C BENTINICK |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 02/12/1993 |
Decision Date | 02/15/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|