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FDA 510(k)

Infrared PT2L Digital No-Touch Thermometer

K-Number: K200710 · 2020-10-01

ApplicantAndon Health Co, Ltd.
Decision Date2020-10-01
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared PT2L Digital No-Touch Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2020-10-01 under 510(k) number K200710. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infrared PT2L Digital No-Touch Thermometer?

Infrared PT2L Digital No-Touch Thermometer is a medical device that received FDA 510(k) clearance on 2020-10-01. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K200710.

When did Infrared PT2L Digital No-Touch Thermometer receive FDA 510(k) clearance?

Infrared PT2L Digital No-Touch Thermometer received FDA 510(k) clearance on 2020-10-01, under 510(k) number K200710.

Who is the listed applicant for Infrared PT2L Digital No-Touch Thermometer?

The FDA 510(k) record lists Andon Health Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared PT2L Digital No-Touch Thermometer?

The FDA product code for Infrared PT2L Digital No-Touch Thermometer is FLL.

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Related Devices (Code: FLL)

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.

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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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