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FDA 510(k)

Infrascanner

K-Number: K211617 · 2022-02-09

ApplicantInfrascan, Inc.
Decision Date2022-02-09
Product CodeOPT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Infrascanner is a medical device manufactured by Infrascan, Inc.. It received FDA 510(k) clearance on 2022-02-09 under approval number K211617. The device is classified under product code OPT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infrascanner?

Infrascanner is a medical device that received FDA 510(k) clearance on 2022-02-09. It is manufactured by Infrascan, Inc.. The 510(k) number is K211617.

When was Infrascanner approved by the FDA?

Infrascanner received FDA 510(k) clearance on 2022-02-09, under approval number K211617.

What company makes Infrascanner?

Infrascanner is manufactured by Infrascan, Inc..

What is the FDA product code for Infrascanner?

The FDA product code for Infrascanner is OPT.

Other Devices by Infrascan, Inc.

K200203Infrascanner K241389Infrascanner Model 2500 (Model 2500)

Related Devices (Code: OPT)

K200203InfrascannerInfrascan, Inc. K241389Infrascanner Model 2500 (Model 2500)Infrascan, 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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