K980369 is an FDA 510(k) clearance for the T.B.Q. RTU. This device is classified as a Disinfectant, Medical Devices (Class I - General Controls, product code LRJ).
Submitted by STERIS Corporation (St. Louis, US). The FDA issued a Cleared decision on February 17, 1998, 18 days after receiving the submission on January 30, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6890.
| 510(k) Number | K980369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 1998 |
| Decision Date | February 17, 1998 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LRJ — Disinfectant, Medical Devices |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6890 |