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FDA 510(k)

Huma RPM (RPM)

K-Number: K230214 · 2023-06-02

ApplicantMedopad, Inc.
Decision Date2023-06-02
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Huma RPM (RPM) is the device name listed in this FDA 510(k) record. The listed applicant is Medopad, Inc.. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K230214. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Huma RPM (RPM)?

Huma RPM (RPM) is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Medopad, Inc.. The 510(k) number is K230214.

When did Huma RPM (RPM) receive FDA 510(k) clearance?

Huma RPM (RPM) received FDA 510(k) clearance on 2023-06-02, under 510(k) number K230214.

Who is the listed applicant for Huma RPM (RPM)?

The FDA 510(k) record lists Medopad, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Huma RPM (RPM)?

The FDA product code for Huma RPM (RPM) is MWI.

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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