The following data is part of a premarket notification filed by Cedaron Medical, Inc. with the FDA for Dexter Isokinetic.
| Device ID | K944732 |
| 510k Number | K944732 |
| Device Name: | DEXTER ISOKINETIC |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | CEDARON MEDICAL, INC. P.O. BOX 2100 Davis, CA 95617 |
| Contact | Karen Bond |
| Correspondent | Karen Bond CEDARON MEDICAL, INC. P.O. BOX 2100 Davis, CA 95617 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-25 |
| Decision Date | 1995-02-03 |