The following data is part of a premarket notification filed by Instratek, Inc. with the FDA for Endotrak System.
| Device ID | K925083 |
| 510k Number | K925083 |
| Device Name: | ENDOTRAK SYSTEM |
| Classification | Arthroscope |
| Applicant | INSTRATEK, INC. 11210 STEEPLECREST SUITE 130 Houston, TX 77065 |
| Contact | Perry Forrester |
| Correspondent | Perry Forrester INSTRATEK, INC. 11210 STEEPLECREST SUITE 130 Houston, TX 77065 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-07 |
| Decision Date | 1993-04-27 |