Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K943509 |
Device Name |
7300 NASAL CPAP SYSTEM |
Applicant |
HEALTHDYNE TECHNOLOGIES, INC. |
1850 PARKWAY PLACE |
MARIETTA,
GA
30067
|
|
Applicant Contact |
TIMOTHY Y COWART |
Correspondent |
HEALTHDYNE TECHNOLOGIES, INC. |
1850 PARKWAY PLACE |
MARIETTA,
GA
30067
|
|
Correspondent Contact |
TIMOTHY Y COWART |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 07/20/1994 |
Decision Date | 08/05/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|