bite away neo— 510(k) K220514

Substantially Equivalent

mibeTec GmbH

FDA 510(k) clearance K220514 for bite away neo, Substantially Equivalent on 2022-06-23. Applicant: mibeTec GmbH.

Clearance details

Applicant: mibeTec GmbH
Product code: Code IRT
Advisory panel: Physical Medicine
Date received: 2022-02-22
Decision date: 2022-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brehna, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code IRT

product code IRT

Injury: 668
Total: 668

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.