FDA 510(k)

Molecular Flow Simulations

K-Number: K201435 · 2021-12-03

Decision Date2021-12-03

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Molecular Flow Simulations is the device name listed in this FDA 510(k) record. The listed applicant is Therataxis, LLC. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K201435. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Molecular Flow Simulations?

Molecular Flow Simulations is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Therataxis, LLC. The 510(k) number is K201435.

When did Molecular Flow Simulations receive FDA 510(k) clearance?

Molecular Flow Simulations received FDA 510(k) clearance on 2021-12-03, under 510(k) number K201435.

Who is the listed applicant for Molecular Flow Simulations?

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

What is the FDA product code for Molecular Flow Simulations?

The FDA product code for Molecular Flow Simulations is HAW.

Related Devices (Code: HAW)

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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.