Device Classification Name |
Compressor, Air, Portable
|
510(k) Number |
K922623 |
Device Name |
NEBULIZER SYSTEM |
Applicant |
HEALTHDYNE, INC. |
1850 PARKWAY PLACE, 12TH FLOOR |
MARIETTA,
GA
30067 -8274
|
|
Applicant Contact |
TIM COWARD |
Correspondent |
HEALTHDYNE, INC. |
1850 PARKWAY PLACE, 12TH FLOOR |
MARIETTA,
GA
30067 -8274
|
|
Correspondent Contact |
TIM COWARD |
Regulation Number | 868.6250
|
Classification Product Code |
|
Date Received | 06/02/1992 |
Decision Date | 12/01/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|