M5 Recorder— 510(k) K202456

Substantially Equivalent

Global Instrumentation, LLC

FDA 510(k) clearance K202456 for M5 Recorder, Substantially Equivalent on 2020-12-29. Applicant: Global Instrumentation, LLC.

Clearance details

Applicant: Global Instrumentation, LLC
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2020-08-27
Decision date: 2020-12-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Manlius, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.