FDA 510(k)

ClearEdge Balance System

K-Number: K183661 · 2019-10-22

Decision Date2019-10-22

Product CodeLXV

DecisionSubstantially Equivalent

Device Summary

ClearEdge Balance System is the device name listed in this FDA 510(k) record. The listed applicant is Quadrant Biosciences. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K183661. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearEdge Balance System?

ClearEdge Balance System is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is Quadrant Biosciences. The 510(k) number is K183661.

When did ClearEdge Balance System receive FDA 510(k) clearance?

ClearEdge Balance System received FDA 510(k) clearance on 2019-10-22, under 510(k) number K183661.

Who is the listed applicant for ClearEdge Balance System?

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

What is the FDA product code for ClearEdge Balance System?

The FDA product code for ClearEdge Balance System is LXV.

Related Devices (Code: LXV)

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.

K220231GyroStimUltrathera Technologies, Inc.K200529OrionInteracoustics A/S K192652TRVInteracoustics A/S K190735EQ BalanceUpright Science, Inc.K173669K-D BalanceKing-Devick Technologies, Inc.

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.