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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 the device name listed in this FDA 510(k) record. The listed applicant is Avails Medical, Inc.. It received FDA 510(k) clearance on 2024-02-08 under 510(k) 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. The listed applicant is Avails Medical, Inc.. The 510(k) number is K231536.

When did eQUANT System receive FDA 510(k) clearance?

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

Who is the listed applicant for eQUANT System?

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

What is the FDA product code for eQUANT System?

The FDA product code for eQUANT System is QZX.

Related Devices (Code: QZX)

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.

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

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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