The following data is part of a premarket notification filed by Biodex Corp. with the FDA for Biodex System 2 Autoprogram.
| Device ID | K915648 |
| 510k Number | K915648 |
| Device Name: | BIODEX SYSTEM 2 AUTOPROGRAM |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | BIODEX CORP. 20 RAMSAY RD. P.O. BOX 702 Shirley, NY 11967 |
| Contact | Clyde Schlein |
| Correspondent | Clyde Schlein BIODEX CORP. 20 RAMSAY RD. P.O. BOX 702 Shirley, NY 11967 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-13 |
| Decision Date | 1992-01-09 |