Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K941008 |
Device Name |
COMPLETE CPR KIT |
Applicant |
MTM HEALTH PRODUCTS LTD. |
2349 FAIRVIEW ST. |
BURLINGTON, ONTARIO, CANADA |
L7R 2E3,
CA
L7R 2E3
|
|
Applicant Contact |
FRANK SNAPE |
Correspondent |
MTM HEALTH PRODUCTS LTD. |
2349 FAIRVIEW ST. |
BURLINGTON, ONTARIO, CANADA |
L7R 2E3,
CA
L7R 2E3
|
|
Correspondent Contact |
FRANK SNAPE |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 03/01/1994 |
Decision Date | 11/10/1994 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|