The following data is part of a premarket notification filed by Biodex Corp. with the FDA for Biodex System.
| Device ID | K860821 |
| 510k Number | K860821 |
| Device Name: | BIODEX SYSTEM |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | BIODEX CORP. 32 CHICHESTER AVE. P.O. BOX 656 Center Moriches, NY 11934 |
| Contact | James Reiss |
| Correspondent | James Reiss BIODEX CORP. 32 CHICHESTER AVE. P.O. BOX 656 Center Moriches, NY 11934 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-04-18 |