Device Classification Name |
exerciser, measuring
|
510(k) Number |
K880032 |
Device Name |
MEDEX MACHINE |
Applicant |
MEDEX, INC. |
1155 NE 77TH ST. |
OCALA,
FL
32670
|
|
Applicant Contact |
ARTHUR JONES |
Correspondent |
MEDEX, INC. |
1155 NE 77TH ST. |
OCALA,
FL
32670
|
|
Correspondent Contact |
ARTHUR JONES |
Regulation Number | 890.5360
|
Classification Product Code |
|
Date Received | 01/05/1988 |
Decision Date | 02/11/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|