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FDA 510(k)

MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER

K-Number: K861623 · 1986-08-19

ApplicantLuxtron
Decision Date1986-08-19
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Luxtron. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K861623. 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 MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER?

MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Luxtron. The 510(k) number is K861623.

When did MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER receive FDA 510(k) clearance?

MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER received FDA 510(k) clearance on 1986-08-19, under 510(k) number K861623.

Who is the listed applicant for MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER?

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

What is the FDA product code for MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER?

The FDA product code for MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER 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 Luxtron 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.

K923189LUXTRON MODEL 3100/3101/3102 MULTICHANNELK841105MULTICHANNEL 2000 FLUOROPTIC THERMOMETK821070BIOMEDICAL FLUOROPTIC

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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