Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K963481 |
Device Name |
ANODYNE CC |
Applicant |
HEYER AMERICA, INC. |
40178 U.S. 19 NORTH |
TARPON SPRINGS,
FL
34689
|
|
Applicant Contact |
ED RANSOM |
Correspondent |
HEYER AMERICA, INC. |
40178 U.S. 19 NORTH |
TARPON SPRINGS,
FL
34689
|
|
Correspondent Contact |
ED RANSOM |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 09/03/1996 |
Decision Date | 08/11/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|