Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K970173 |
Device Name |
MODEL 1700 TRANQUILITY BILEVEL 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 | 01/16/1997 |
Decision Date | 04/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|