FDA 510(k)

DCM (PW-DCM)

K-Number: K243513 · 2025-04-16

Decision Date2025-04-16

Product CodeLEL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DCM (PW-DCM) is the device name listed in this FDA 510(k) record. The listed applicant is Pneumowave, Ltd.. It received FDA 510(k) clearance on 2025-04-16 under 510(k) number K243513. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DCM (PW-DCM)?

DCM (PW-DCM) is a medical device that received FDA 510(k) clearance on 2025-04-16. The listed applicant is Pneumowave, Ltd.. The 510(k) number is K243513.

When did DCM (PW-DCM) receive FDA 510(k) clearance?

DCM (PW-DCM) received FDA 510(k) clearance on 2025-04-16, under 510(k) number K243513.

Who is the listed applicant for DCM (PW-DCM)?

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

What is the FDA product code for DCM (PW-DCM)?

The FDA product code for DCM (PW-DCM) is LEL.

Related Devices (Code: LEL)

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

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