The following data is part of a premarket notification filed by Cybex with the FDA for Cybex 770.
Device ID | K950095 |
510k Number | K950095 |
Device Name: | CYBEX 770 |
Classification | System, Isokinetic Testing And Evaluation |
Applicant | CYBEX 2100 SMITHTOWN AVE. Ronkonkoma, NY 11779 |
Contact | Robert Cohen |
Correspondent | Robert Cohen CYBEX 2100 SMITHTOWN AVE. 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 | 1995-01-10 |
Decision Date | 1995-06-21 |