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FDA 510(k)

Infrared Thermometer, Model: HW-1

K-Number: K211583 · 2021-09-03

ApplicantDongguan Simzo Electronic Technology Co., Ltd.
Decision Date2021-09-03
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer, Model: HW-1 is a medical device manufactured by Dongguan Simzo Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-03 under approval number K211583. 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 Thermometer, Model: HW-1?

Infrared Thermometer, Model: HW-1 is a medical device that received FDA 510(k) clearance on 2021-09-03. It is manufactured by Dongguan Simzo Electronic Technology Co., Ltd.. The 510(k) number is K211583.

When was Infrared Thermometer, Model: HW-1 approved by the FDA?

Infrared Thermometer, Model: HW-1 received FDA 510(k) clearance on 2021-09-03, under approval number K211583.

What company makes Infrared Thermometer, Model: HW-1?

Infrared Thermometer, Model: HW-1 is manufactured by Dongguan Simzo Electronic Technology Co., Ltd..

What is the FDA product code for Infrared Thermometer, Model: HW-1?

The FDA product code for Infrared Thermometer, Model: HW-1 is FLL.

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Other Devices by Dongguan Simzo Electronic Technology Co., Ltd.

K173048No-contact Forehead Thermometer K230379Portable (Ultrasonic) Nebulizer

Related Devices (Code: FLL)

K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd. K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd. K161211Digital ThermometerBiocare Asia Corporation , Ltd. K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd.

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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