Device Classification Name |
oximeter
|
510(k) Number |
K022168 |
Device Name |
ENVOY |
Applicant |
MENNEN MEDICAL LTD. |
10123 MAIN ST. |
CLARENCE,
NY
14031
|
|
Applicant Contact |
DAVID P JOHNSON |
Correspondent |
MENNEN MEDICAL LTD. |
10123 MAIN ST. |
CLARENCE,
NY
14031
|
|
Correspondent Contact |
DAVID P JOHNSON |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/03/2002 |
Decision Date | 08/01/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|