GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS— 510(k) K121433

Substantially Equivalent

Hmd Biomedical, Inc.

FDA 510(k) clearance K121433 for GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS, Substantially Equivalent on 2013-02-14. Applicant: Hmd Biomedical, Inc..

Clearance details

Applicant: Hmd Biomedical, Inc.
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 2012-05-14
Decision date: 2013-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xinpu Township, Hsinchu County, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFR

product code LFR

Death: 3
Malfunction: 1,634
Total: 1,637

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.