Device Classification Name |
electrode, electrocardiograph
|
510(k) Number |
K991105 |
Device Name |
ECG ELECTRODE (VARIOUS) |
Applicant |
CONMED CORP. |
310 BROAD ST. |
UTICA,
NY
13501 -1203
|
|
Applicant Contact |
IRA D DUESLER |
Correspondent |
CONMED CORP. |
310 BROAD ST. |
UTICA,
NY
13501 -1203
|
|
Correspondent Contact |
IRA D DUESLER |
Regulation Number | 870.2360
|
Classification Product Code |
|
Date Received | 04/01/1999 |
Decision Date | 11/26/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|