The following data is part of a premarket notification filed by Cybex with the FDA for Edi 320.
| Device ID | K873599 | 
| 510k Number | K873599 | 
| Device Name: | EDI 320 | 
| Classification | Goniometer, Ac-powered | 
| Applicant | CYBEX 2100 SMITHTOWN AVE. P.O. BOX 9003 Ronkonkoma, NY 11779 | 
| Contact | William Sauer | 
| Correspondent | William Sauer CYBEX 2100 SMITHTOWN AVE. P.O. BOX 9003 Ronkonkoma, NY 11779 | 
| Product Code | KQX | 
| CFR Regulation Number | 888.1500 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1987-09-04 | 
| Decision Date | 1987-10-16 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  EDI 320  73672401  1516283 Dead/Cancelled | LUMEX, INC. 1987-07-16 |