inHEART MODELS— 510(k) K220727

Substantially Equivalent

Inheart, Sas

FDA 510(k) clearance K220727 for inHEART MODELS, Substantially Equivalent on 2022-05-10. Applicant: Inheart, Sas.

Clearance details

Applicant: Inheart, Sas
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-03-14
Decision date: 2022-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pessac, FR

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.