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FDA 510(k)

eQUANT System

K-Number: K231536 · 2024-02-08

ApplicantAvails Medical, Inc.
Decision Date2024-02-08
Product CodeQZX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

eQUANT System is a medical device manufactured by Avails Medical, Inc.. It received FDA 510(k) clearance on 2024-02-08 under approval number K231536. The device is classified under product code QZX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eQUANT System?

eQUANT System is a medical device that received FDA 510(k) clearance on 2024-02-08. It is manufactured by Avails Medical, Inc.. The 510(k) number is K231536.

When was eQUANT System approved by the FDA?

eQUANT System received FDA 510(k) clearance on 2024-02-08, under approval number K231536.

What company makes eQUANT System?

eQUANT System is manufactured by Avails Medical, Inc..

What is the FDA product code for eQUANT System?

The FDA product code for eQUANT System is QZX.

Related Devices (Code: QZX)

K223493PBC Separator with Selux AST SystemSelux Diagnostics, Inc. K244044PBC Separator with Selux AST SystemSelux Diagnostics, Inc.

Official Source

View on FDA Database →

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