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FDA 510(k)

Non-Contact Infrared Thermometer, model HL710H

K-Number: K211744 · 2021-11-24

ApplicantHealth & Life Co., Ltd.
Decision Date2021-11-24
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-Contact Infrared Thermometer, model HL710H is the device name listed in this FDA 510(k) record. The listed applicant is Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2021-11-24 under 510(k) number K211744. 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 Non-Contact Infrared Thermometer, model HL710H?

Non-Contact Infrared Thermometer, model HL710H is a medical device that received FDA 510(k) clearance on 2021-11-24. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K211744.

When did Non-Contact Infrared Thermometer, model HL710H receive FDA 510(k) clearance?

Non-Contact Infrared Thermometer, model HL710H received FDA 510(k) clearance on 2021-11-24, under 510(k) number K211744.

Who is the listed applicant for Non-Contact Infrared Thermometer, model HL710H?

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

What is the FDA product code for Non-Contact Infrared Thermometer, model HL710H?

The FDA product code for Non-Contact Infrared Thermometer, model HL710H 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

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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