Huma RPM (RPM)— 510(k) K230214

Name: FDA 510(k) clearance K230214
Creator: U.S. Food and Drug Administration
Published: 2023-06-02

Substantially Equivalent

Medopad, Inc.

FDA 510(k) clearance K230214 for Huma RPM (RPM), Substantially Equivalent on 2023-06-02. Applicant: Medopad, Inc.. Device class: 2.

Clearance details

Applicant: Medopad, Inc.
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2023-01-26
Decision date: 2023-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.