K932047 is an FDA 510(k) clearance for the WAVICIDE MONITOR STRIPS. This device is classified as a Sterilant, Medical Devices (Class II - Special Controls, product code MED).
Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on June 2, 1994, 401 days after receiving the submission on April 27, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6885.
| 510(k) Number | K932047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1993 |
| Decision Date | June 02, 1994 |
| Days to Decision | 401 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | MED — Sterilant, Medical Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6885 |