FDA 510(k)

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)

K-Number: K211776 · 2022-03-01

ApplicantMicrolife Intellectual Property GmbH

Decision Date2022-03-01

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K211776. 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 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)?

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K211776.

When did Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) receive FDA 510(k) clearance?

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) received FDA 510(k) clearance on 2022-03-01, under 510(k) number K211776.

Who is the listed applicant for Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)?

The FDA 510(k) record lists Microlife Intellectual Property GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)?

The FDA product code for Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is FLL.

Related Clinical Trials

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.

NCT07231653Home Monitoring Study for Surgical PatientsNOT_YET_RECRUITING NCT07762053Clinical Investigation of Eye C Better's Photobionic Intraocular Pressure Biomonitor TonometerNOT_YET_RECRUITING

Other records listing Microlife Intellectual Property GmbH as applicant

K230075Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K K222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B K202729Microlife Upper Arm Automatic Digital Blood Pressure Monitor K200738Microlife Upper Arm Automatic Digital Blood Pressure Monitor

View all 18 devices →

Related Devices (Code: FLL)

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology 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.