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

FDA 510(k)

A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER

K-Number: K993116 · 2000-04-12

ApplicantA&D Engineering, Inc.
Decision Date2000-04-12
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER is the device name listed in this FDA 510(k) record. The listed applicant is A&D Engineering, Inc.. It received FDA 510(k) clearance on 2000-04-12 under 510(k) number K993116. 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 A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER?

A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER is a medical device that received FDA 510(k) clearance on 2000-04-12. The listed applicant is A&D Engineering, Inc.. The 510(k) number is K993116.

When did A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER receive FDA 510(k) clearance?

A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER received FDA 510(k) clearance on 2000-04-12, under 510(k) number K993116.

Who is the listed applicant for A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER?

The FDA 510(k) record lists A&D Engineering, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER?

The FDA product code for A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing A&D Engineering, Inc. as applicant

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.

K082734A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITORK062027A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITORK061456A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITORK043217A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITORK042967A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512K040371A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR

View all 34 devices →

Related Devices (Code: FLL)

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.

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.

↑