K930043 is an FDA 510(k) clearance for the ACU-EVAC. This device is classified as a Apparatus, Exhaust, Surgical (Class II - Special Controls, product code FYD).
Submitted by Acuderm, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on February 9, 1994, 400 days after receiving the submission on January 5, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.5070.
| 510(k) Number | K930043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1993 |
| Decision Date | February 09, 1994 |
| Days to Decision | 400 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYD — Apparatus, Exhaust, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5070 |