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 |