Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K950849 |
Device Name |
MODEL #7354 |
Applicant |
DEVILBISS HEALTH CARE, INC. |
P.O. BOX 635 |
SOMERSET,
PA
15501 -0635
|
|
Applicant Contact |
MARK D'ANGELO |
Correspondent |
DEVILBISS HEALTH CARE, INC. |
P.O. BOX 635 |
SOMERSET,
PA
15501 -0635
|
|
Correspondent Contact |
MARK D'ANGELO |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 02/24/1995 |
Decision Date | 02/08/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|