Device Classification Name |
gas-machine, anesthesia
|
510(k) Number |
K000995 |
Device Name |
NARKOMAT, MODEL 2000 |
Applicant |
HEYER AMERICA, INC. |
3234 ELLA LN. |
NEW PORT RICHEY,
FL
34655
|
|
Applicant Contact |
ART WARD |
Correspondent |
HEYER AMERICA, INC. |
3234 ELLA LN. |
NEW PORT RICHEY,
FL
34655
|
|
Correspondent Contact |
ART WARD |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 03/28/2000 |
Decision Date | 10/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|