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FDA 510(k)

WAVE Clinical Platform

K-Number: K171056 · 2018-01-04

ApplicantExcel Medical Electronics, LLC
Decision Date2018-01-04
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WAVE Clinical Platform is a medical device manufactured by Excel Medical Electronics, LLC. It received FDA 510(k) clearance on 2018-01-04 under approval number K171056. 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 WAVE Clinical Platform?

WAVE Clinical Platform is a medical device that received FDA 510(k) clearance on 2018-01-04. It is manufactured by Excel Medical Electronics, LLC. The 510(k) number is K171056.

When was WAVE Clinical Platform approved by the FDA?

WAVE Clinical Platform received FDA 510(k) clearance on 2018-01-04, under approval number K171056.

What company makes WAVE Clinical Platform?

WAVE Clinical Platform is manufactured by Excel Medical Electronics, LLC.

What is the FDA product code for WAVE Clinical Platform?

The FDA product code for WAVE Clinical Platform is MWI.

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Related PubMed Literature

PMID: 28005723 Light-Driven Contact Hearing Aid for Broad-Spectrum Amplification: Safety and Effectiveness Pivotal Study. Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology (2017)

Related Devices (Code: MWI)

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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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