Device Classification Name |
Ventilator, Continuous, Non-Life-Supporting
|
510(k) Number |
K962517 |
Device Name |
MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV |
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 | 868.5895
|
Classification Product Code |
|
Date Received | 06/27/1996 |
Decision Date | 02/20/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|