The following data is part of a premarket notification filed by Inhalation Therapy Equipment, Co. with the FDA for Uni-set.
| Device ID | K820128 |
| 510k Number | K820128 |
| Device Name: | UNI-SET |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | INHALATION THERAPY EQUIPMENT, CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-18 |
| Decision Date | 1982-03-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() UNI-SET 81001992 1001992 Dead/Cancelled |
General Motors Corporation 0000-00-00 |
![]() UNI-SET 73313373 1196123 Dead/Cancelled |
General Motors Corporation 1981-06-05 |
![]() UNI-SET 73091025 1064465 Live/Registered |
KNIFF WOODCRAFT CORPORATION 1976-06-21 |