The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Isokinetic System, Testing And Evaluation.
| Device ID | K875235 |
| 510k Number | K875235 |
| Device Name: | ISOKINETIC SYSTEM, TESTING AND EVALUATION |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Contact | Robert Moore |
| Correspondent | Robert Moore ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-22 |
| Decision Date | 1988-01-19 |