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FDA 510(k)

C3 Wave System

K-Number: K180567 · 2018-04-12

ApplicantMedical Components, Inc. (dba MedComp)
Decision Date2018-04-12
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

C3 Wave System is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc. (dba MedComp). It received FDA 510(k) clearance on 2018-04-12 under 510(k) number K180567. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C3 Wave System?

C3 Wave System is a medical device that received FDA 510(k) clearance on 2018-04-12. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K180567.

When did C3 Wave System receive FDA 510(k) clearance?

C3 Wave System received FDA 510(k) clearance on 2018-04-12, under 510(k) number K180567.

Who is the listed applicant for C3 Wave System?

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

What is the FDA product code for C3 Wave System?

The FDA product code for C3 Wave System is LJS.

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Related Devices (Code: LJS)

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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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