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 the device name listed in this FDA 510(k) record. The listed applicant is Infrascan, Inc.. It received FDA 510(k) clearance on 2024-12-12 under 510(k) 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. The listed applicant is Infrascan, Inc.. The 510(k) number is K241389.

When did Infrascanner Model 2500 (Model 2500) receive FDA 510(k) clearance?

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

Who is the listed applicant for Infrascanner Model 2500 (Model 2500)?

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

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 records listing Infrascan, Inc. as applicant

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.

K211617Infrascanner K200203Infrascanner

Related Devices (Code: OPT)

K211617InfrascannerInfrascan, Inc.K200203InfrascannerInfrascan, Inc.

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.