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FDA 510(k)

DCM (PW-DCM)

K-Number: K243513 · 2025-04-16

ApplicantPneumowave, Ltd.
Decision Date2025-04-16
Product CodeLEL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DCM (PW-DCM) is a medical device manufactured by Pneumowave, Ltd.. It received FDA 510(k) clearance on 2025-04-16 under approval 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. It is manufactured by Pneumowave, Ltd.. The 510(k) number is K243513.

When was DCM (PW-DCM) approved by the FDA?

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

What company makes DCM (PW-DCM)?

DCM (PW-DCM) is manufactured by Pneumowave, Ltd..

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

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

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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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