K983947 is an FDA 510(k) clearance for the AMERSE 2. 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 December 4, 1998, 29 days after receiving the submission on November 5, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6890.
| 510(k) Number | K983947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1998 |
| Decision Date | December 04, 1998 |
| Days to Decision | 29 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 |