HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER— 510(k) K014025

Substantially Equivalent

Hommed, LLC

FDA 510(k) clearance K014025 for HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER, Substantially Equivalent on 2002-04-09. Applicant: Hommed, LLC.

Clearance details

Applicant: Hommed, LLC
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2001-12-06
Decision date: 2002-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.