Device Classification Name |
conserver, oxygen
|
510(k) Number |
K964541 |
Device Name |
SANPO I |
Applicant |
KOIKE MEDICAL CO. |
1800 M STREET, N.W. |
WASHINGTON,
DC
20036 -5869
|
|
Applicant Contact |
STEPHEN P MAHINKA |
Correspondent |
KOIKE MEDICAL CO. |
1800 M STREET, N.W. |
WASHINGTON,
DC
20036 -5869
|
|
Correspondent Contact |
STEPHEN P MAHINKA |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 11/01/1996 |
Decision Date | 09/26/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|