Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

iHealth infrared Ear thermometer PT5

K-Number: K212598 · 2022-01-28

ApplicantAndon Health Co, Ltd.
Decision Date2022-01-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

iHealth infrared Ear thermometer PT5 is a medical device manufactured by Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2022-01-28 under approval number K212598. 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 iHealth infrared Ear thermometer PT5?

iHealth infrared Ear thermometer PT5 is a medical device that received FDA 510(k) clearance on 2022-01-28. It is manufactured by Andon Health Co, Ltd.. The 510(k) number is K212598.

When was iHealth infrared Ear thermometer PT5 approved by the FDA?

iHealth infrared Ear thermometer PT5 received FDA 510(k) clearance on 2022-01-28, under approval number K212598.

What company makes iHealth infrared Ear thermometer PT5?

iHealth infrared Ear thermometer PT5 is manufactured by Andon Health Co, Ltd..

What is the FDA product code for iHealth infrared Ear thermometer PT5?

The FDA product code for iHealth infrared Ear thermometer PT5 is FLL.

Other Devices by Andon Health Co, Ltd.

K153286iHealth Align Gluco-Monitoring system K153278Wireless Smart Gluco-Monitoring System K160565Fully Automatic Electronic Blood Pressure Monitor K160563Fully Automatic Electronic Blood Pressure Monitor K160014iHealth Track Blood Pressure Monitor K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

View all 31 devices →

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.

↑