The following data is part of a premarket notification filed by Trek Medical Products, Inc. with the FDA for Fts-200 Gas System.
| Device ID | K920944 |
| 510k Number | K920944 |
| Device Name: | FTS-200 GAS SYSTEM |
| Classification | Gas-machine, Anesthesia |
| Applicant | TREK MEDICAL PRODUCTS, INC. 820 SWAN DR. P.O. BOX B Mukwonago, WI 53149 |
| Contact | Ronald Hueneke |
| Correspondent | Ronald Hueneke TREK MEDICAL PRODUCTS, INC. 820 SWAN DR. P.O. BOX B Mukwonago, WI 53149 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-02 |
| Decision Date | 1992-05-29 |