ECHONET— 510(k) K954860

Substantially Equivalent

Heartlab, Inc.

FDA 510(k) clearance K954860 for ECHONET, Substantially Equivalent on 1995-12-21. Applicant: Heartlab, Inc..

Clearance details

Applicant: Heartlab, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1995-10-23
Decision date: 1995-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, RI, US

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.