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FDA 510(k)

Thermidas IR System (ThIR-A615)

K-Number: K200999 · 2021-01-06

ApplicantThermidas Americas, Inc.
Decision Date2021-01-06
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Thermidas IR System (ThIR-A615) is a medical device manufactured by Thermidas Americas, Inc.. It received FDA 510(k) clearance on 2021-01-06 under approval number K200999. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thermidas IR System (ThIR-A615)?

Thermidas IR System (ThIR-A615) is a medical device that received FDA 510(k) clearance on 2021-01-06. It is manufactured by Thermidas Americas, Inc.. The 510(k) number is K200999.

When was Thermidas IR System (ThIR-A615) approved by the FDA?

Thermidas IR System (ThIR-A615) received FDA 510(k) clearance on 2021-01-06, under approval number K200999.

What company makes Thermidas IR System (ThIR-A615)?

Thermidas IR System (ThIR-A615) is manufactured by Thermidas Americas, Inc..

What is the FDA product code for Thermidas IR System (ThIR-A615)?

The FDA product code for Thermidas IR System (ThIR-A615) is LHQ.

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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.

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