The following data is part of a premarket notification filed by Biodex Medical Systems, Inc. with the FDA for Biodex System 3 Model S3s-ap And Model S3d-3ap.
| Device ID | K951770 |
| 510k Number | K951770 |
| Device Name: | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | BIODEX MEDICAL SYSTEMS, INC. 20 RAMSAY RD. BOX 702 Shirley, NY 11967 -0702 |
| Contact | Clyde Schlein |
| Correspondent | Clyde Schlein BIODEX MEDICAL SYSTEMS, INC. 20 RAMSAY RD. BOX 702 Shirley, NY 11967 -0702 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-17 |
| Decision Date | 1995-11-16 |
| Summary: | summary |