The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Medex Machine.
| Device ID | K880032 |
| 510k Number | K880032 |
| Device Name: | MEDEX MACHINE |
| Classification | Exerciser, Measuring |
| Applicant | MEDEX, INC. 1155 NE 77TH ST. Ocala, FL 32670 |
| Contact | Arthur Jones |
| Correspondent | Arthur Jones MEDEX, INC. 1155 NE 77TH ST. Ocala, FL 32670 |
| Product Code | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-05 |
| Decision Date | 1988-02-11 |