FDA 510(k)

M-Wave

K-Number: K233485 · 2024-01-26

Decision Date2024-01-26

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

M-Wave is the device name listed in this FDA 510(k) record. The listed applicant is Zynex Medical, Inc.. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K233485. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M-Wave?

M-Wave is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Zynex Medical, Inc.. The 510(k) number is K233485.

When did M-Wave receive FDA 510(k) clearance?

M-Wave received FDA 510(k) clearance on 2024-01-26, under 510(k) number K233485.

Who is the listed applicant for M-Wave?

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

What is the FDA product code for M-Wave?

The FDA product code for M-Wave is IPF.

Other records listing Zynex Medical, Inc. as applicant

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.

K223217Zynex Monitoring System, Model CM-1600 K191697Cardiac Monitor 1500

Related Devices (Code: IPF)

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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.