Device Classification Name |
electrode, cutaneous
|
510(k) Number |
K915333 |
Device Name |
ELECTRODE USING PROMEON RG-60 SERIES GEL |
Applicant |
LABELTAPE MEDITECT, INC. |
4275 AIRWEST DR., S.E. |
P.O. BOX 8823 |
GRAND RAPIDS,
MI
49508
|
|
Applicant Contact |
LORA L.JONES |
Correspondent |
LABELTAPE MEDITECT, INC. |
4275 AIRWEST DR., S.E. |
P.O. BOX 8823 |
GRAND RAPIDS,
MI
49508
|
|
Correspondent Contact |
LORA L.JONES |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 11/26/1991 |
Decision Date | 01/14/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|