Device Classification Name |
Electrode, Electrocardiograph
|
510(k) Number |
K884980 |
Device Name |
F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM |
Applicant |
S & W MEDICO TEKNIK |
HERSTEDVANG 8 |
DK-2620 ALBERTSLUND |
DENMARK,
DK
|
|
Applicant Contact |
LISBETH ISBRANDT |
Correspondent |
S & W MEDICO TEKNIK |
HERSTEDVANG 8 |
DK-2620 ALBERTSLUND |
DENMARK,
DK
|
|
Correspondent Contact |
LISBETH ISBRANDT |
Regulation Number | 870.2360 |
Classification Product Code |
|
Date Received | 11/29/1988 |
Decision Date | 05/01/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|