Device Classification Name |
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
|
510(k) Number |
K894244 |
Device Name |
DEVILBISS MODEL 8500D AND 8500D-608 |
Applicant |
DEVILBISS HEALTH CARE, INC. |
1200 EAST MAIN ST. |
P.O.BOX 635 |
SOMERSET,
PA
15501 -0635
|
|
Applicant Contact |
TERRY O'BRIEN |
Correspondent |
DEVILBISS HEALTH CARE, INC. |
1200 EAST MAIN ST. |
P.O.BOX 635 |
SOMERSET,
PA
15501 -0635
|
|
Correspondent Contact |
TERRY O'BRIEN |
Regulation Number | 868.5640
|
Classification Product Code |
|
Date Received | 06/21/1989 |
Decision Date | 10/06/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|