K243852 is an FDA 510(k) clearance for the Elfor-L. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Elfi-Tech , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on April 14, 2025, 119 days after receiving the submission on December 16, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K243852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2024 |
| Decision Date | April 14, 2025 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | DPW - Flowmeter, Blood, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2100 |