CarnaLife Holo— 510(k) K221870

Substantially Equivalent

Medapp S.A.

FDA 510(k) clearance K221870 for CarnaLife Holo, Substantially Equivalent on 2023-05-01. Applicant: Medapp S.A..

Clearance details

Applicant: Medapp S.A.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-06-28
Decision date: 2023-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Krakow, PL

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.