FDA 510(k)

ANAM Test System

K-Number: K201376 · 2021-03-25

Decision Date2021-03-25

Product CodePOM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ANAM Test System is the device name listed in this FDA 510(k) record. The listed applicant is Vista Lifesciences, Inc.. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K201376. The device is classified under product code POM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANAM Test System?

ANAM Test System is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Vista Lifesciences, Inc.. The 510(k) number is K201376.

When did ANAM Test System receive FDA 510(k) clearance?

ANAM Test System received FDA 510(k) clearance on 2021-03-25, under 510(k) number K201376.

Who is the listed applicant for ANAM Test System?

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

What is the FDA product code for ANAM Test System?

The FDA product code for ANAM Test System is POM.

Related Devices (Code: POM)

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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.