The following data is part of a premarket notification filed by Tri-tech, Inc. with the FDA for Tritec Doc Tm.
| Device ID | K813075 |
| 510k Number | K813075 |
| Device Name: | TRITEC DOC TM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | TRI-TECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-02 |
| Decision Date | 1981-12-09 |