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FDA 510(k)

Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311

K-Number: K212257 · 2022-05-04

ApplicantAlicn Medical Shenzhen, Inc.
Decision Date2022-05-04
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 is a medical device manufactured by Alicn Medical Shenzhen, Inc.. It received FDA 510(k) clearance on 2022-05-04 under approval number K212257. 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 Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311?

Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 is a medical device that received FDA 510(k) clearance on 2022-05-04. It is manufactured by Alicn Medical Shenzhen, Inc.. The 510(k) number is K212257.

When was Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 approved by the FDA?

Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 received FDA 510(k) clearance on 2022-05-04, under approval number K212257.

What company makes Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311?

Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 is manufactured by Alicn Medical Shenzhen, Inc..

What is the FDA product code for Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311?

The FDA product code for Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 is FLL.

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Other Devices by Alicn Medical Shenzhen, Inc.

K210563Arm Blood Pressure Monitor K221913Arm Blood Pressure Monitor K210937Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 K210565Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 K212877Arm Blood Pressure Monitor K210564Infrared Thermometer

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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

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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