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 |