FDA 510(k)

MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1

K-Number: K000969 · 2000-08-22

Decision Date2000-08-22

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Corp.. It received FDA 510(k) clearance on 2000-08-22 under 510(k) number K000969. 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 DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1?

MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 is a medical device that received FDA 510(k) clearance on 2000-08-22. The listed applicant is Microlife Corp.. The 510(k) number is K000969.

When did MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 receive FDA 510(k) clearance?

MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 received FDA 510(k) clearance on 2000-08-22, under 510(k) number K000969.

Who is the listed applicant for MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1?

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

What is the FDA product code for MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1?

The FDA product code for MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Microlife Corp. as applicant

K122013MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)K080337MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D K073398MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100)K073397MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50)K041411MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP K031024MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100

View all 13 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.