Device Classification Name |
Unit, Liquid-Oxygen, Portable
|
510(k) Number |
K971545 |
Device Name |
PROTEGE LIQUID OXYGEN SYSTEM |
Applicant |
HEALTHDYNE TECHNOLOGIES, INC. |
933 WESTERN DR. |
INDIANAPOLIS,
IN
46241
|
|
Applicant Contact |
JAY HAYES |
Correspondent |
HEALTHDYNE TECHNOLOGIES, INC. |
933 WESTERN DR. |
INDIANAPOLIS,
IN
46241
|
|
Correspondent Contact |
JAY HAYES |
Regulation Number | 868.5655
|
Classification Product Code |
|
Date Received | 04/28/1997 |
Decision Date | 07/25/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|