K945374 is an FDA 510(k) clearance for the ACU-HALT, submitted by Eva-Health USA, Inc. (Staten Island, US). The FDA issued a Cleared decision on August 9, 1995, 280 days after receiving the submission on November 2, 1994. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K945374 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 02, 1994 |
| Decision Date | August 09, 1995 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | LDQ |
| Device Class | — |