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FDA 510(k)

Infrared Non-contact Thermometer, Model ACT8100

K-Number: K162509 · 2017-03-10

ApplicantEasywell Biomedicals, Inc.
Decision Date2017-03-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Non-contact Thermometer, Model ACT8100 is a medical device manufactured by Easywell Biomedicals, Inc.. It received FDA 510(k) clearance on 2017-03-10 under approval number K162509. 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 Non-contact Thermometer, Model ACT8100?

Infrared Non-contact Thermometer, Model ACT8100 is a medical device that received FDA 510(k) clearance on 2017-03-10. It is manufactured by Easywell Biomedicals, Inc.. The 510(k) number is K162509.

When was Infrared Non-contact Thermometer, Model ACT8100 approved by the FDA?

Infrared Non-contact Thermometer, Model ACT8100 received FDA 510(k) clearance on 2017-03-10, under approval number K162509.

What company makes Infrared Non-contact Thermometer, Model ACT8100?

Infrared Non-contact Thermometer, Model ACT8100 is manufactured by Easywell Biomedicals, Inc..

What is the FDA product code for Infrared Non-contact Thermometer, Model ACT8100?

The FDA product code for Infrared Non-contact Thermometer, Model ACT8100 is FLL.

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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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