The following data is part of a premarket notification filed by Cybex with the FDA for Cybex 340.
Device ID | K872911 |
510k Number | K872911 |
Device Name: | CYBEX 340 |
Classification | System, Isokinetic Testing And Evaluation |
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 | IKK |
CFR Regulation Number | 890.1925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-24 |
Decision Date | 1987-09-24 |