contact forte Alpha— 510(k) K243041

Substantially Equivalent

Bhm-Tech Produktionsgesellschaft Mbh

FDA 510(k) clearance K243041 for contact forte Alpha, Substantially Equivalent on 2025-04-25. Applicant: Bhm-Tech Produktionsgesellschaft Mbh.

Clearance details

Applicant: Bhm-Tech Produktionsgesellschaft Mbh
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 2024-09-27
Decision date: 2025-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grafenschachen, AT

Download summary PDF View on FDA.gov ↗

Adverse events under product code LXB

product code LXB

Injury: 2,334
Total: 2,334

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.