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FDA 510(k)

Infrascanner Model 2500 (Model 2500)

K-Number: K241389 · 2024-12-12

Decision Date2024-12-12
Product CodeOPT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Infrascanner Model 2500 (Model 2500) is a medical device manufactured by Infrascan, Inc.. It received FDA 510(k) clearance on 2024-12-12 under approval number K241389. 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 Model 2500 (Model 2500)?

Infrascanner Model 2500 (Model 2500) is a medical device that received FDA 510(k) clearance on 2024-12-12. It is manufactured by Infrascan, Inc.. The 510(k) number is K241389.

When was Infrascanner Model 2500 (Model 2500) approved by the FDA?

Infrascanner Model 2500 (Model 2500) received FDA 510(k) clearance on 2024-12-12, under approval number K241389.

What company makes Infrascanner Model 2500 (Model 2500)?

Infrascanner Model 2500 (Model 2500) is manufactured by Infrascan, Inc..

What is the FDA product code for Infrascanner Model 2500 (Model 2500)?

The FDA product code for Infrascanner Model 2500 (Model 2500) is OPT.

Other Devices by Infrascan, Inc.

Related Devices (Code: OPT)

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.