The following data is part of a premarket notification filed by Biodex Medical Systems, Inc. with the FDA for Compex 2.
| Device ID | K940301 |
| 510k Number | K940301 |
| Device Name: | COMPEX 2 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | BIODEX MEDICAL SYSTEMS, INC. BROOKHAVEN R & D PLAZA 20 RAMSEY RD., P.O. BOX 702 Shirley, NY 11967 -0702 |
| Contact | Clyde Schein |
| Correspondent | Clyde Schein BIODEX MEDICAL SYSTEMS, INC. BROOKHAVEN R & D PLAZA 20 RAMSEY RD., P.O. BOX 702 Shirley, NY 11967 -0702 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-24 |
| Decision Date | 1994-12-28 |