Device Classification Name |
Stimulator, Electrical, Transcutaneous, For Arthritis
|
510(k) Number |
K983228 |
Device Name |
BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 |
Applicant |
MURRAY ELECTRONICS |
260 SCHILLING CIRCLE |
HUNT VALLEY,
MD
21031
|
|
Applicant Contact |
KENT C HOFFMAN |
Correspondent |
MURRAY ELECTRONICS |
260 SCHILLING CIRCLE |
HUNT VALLEY,
MD
21031
|
|
Correspondent Contact |
KENT C HOFFMAN |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 09/15/1998 |
Decision Date | 03/15/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|