GENESIS OTC MONITOR— 510(k) K061087

Substantially Equivalent

Honeywell Hommed, LLC

FDA 510(k) clearance K061087 for GENESIS OTC MONITOR, Substantially Equivalent on 2006-06-09. Applicant: Honeywell Hommed, LLC.

Clearance details

Applicant: Honeywell Hommed, LLC
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2006-04-18
Decision date: 2006-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.