Device Classification Name |
electrode, cutaneous
|
510(k) Number |
K944543 |
Device Name |
BIOFLEX GARMENTS, ASSORTED MODELS |
Applicant |
BIOFLEX, INC. |
736 KENWICK RD. |
COLUMBUS,
OH
43209
|
|
Applicant Contact |
PHILIP MUCCIO |
Correspondent |
BIOFLEX, INC. |
736 KENWICK RD. |
COLUMBUS,
OH
43209
|
|
Correspondent Contact |
PHILIP MUCCIO |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 09/15/1994 |
Decision Date | 07/19/1995 |
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
|
|
|