Device Classification Name |
Conserver, Oxygen
|
510(k) Number |
K970371 |
Device Name |
FLOTEC OXYSAVRR (S) |
Applicant |
FLOTEC, INC. |
8132 WOODLAND DR. |
INDIANAPOLIS,
IN
46278
|
|
Applicant Contact |
GILBERT DAVIDSON |
Correspondent |
FLOTEC, INC. |
8132 WOODLAND DR. |
INDIANAPOLIS,
IN
46278
|
|
Correspondent Contact |
GILBERT DAVIDSON |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 01/31/1997 |
Decision Date | 07/10/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|