GENESIS DM MODEL: 6053000A1— 510(k) K101242

Substantially Equivalent

Honeywell Hommed, LLC

FDA 510(k) clearance K101242 for GENESIS DM MODEL: 6053000A1, Substantially Equivalent on 2010-06-11. Applicant: Honeywell Hommed, LLC.

Clearance details

Applicant: Honeywell Hommed, LLC
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2010-05-03
Decision date: 2010-06-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Brookfield, WI, US

Download summary PDF View on FDA.gov ↗

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.