GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H— 510(k) K092970

Substantially Equivalent

General Meditech, Inc.

FDA 510(k) clearance K092970 for GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H, Substantially Equivalent on 2010-02-02. Applicant: General Meditech, Inc..

Clearance details

Applicant: General Meditech, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2009-09-25
Decision date: 2010-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.