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FDA 510(k)

TEMPTOUCH DERMAL THERMOMETER

K-Number: K050137 · 2005-03-18

ApplicantXilas Medical, Inc.
Decision Date2005-03-18
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEMPTOUCH DERMAL THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Xilas Medical, Inc.. It received FDA 510(k) clearance on 2005-03-18 under 510(k) number K050137. 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 TEMPTOUCH DERMAL THERMOMETER?

TEMPTOUCH DERMAL THERMOMETER is a medical device that received FDA 510(k) clearance on 2005-03-18. The listed applicant is Xilas Medical, Inc.. The 510(k) number is K050137.

When did TEMPTOUCH DERMAL THERMOMETER receive FDA 510(k) clearance?

TEMPTOUCH DERMAL THERMOMETER received FDA 510(k) clearance on 2005-03-18, under 510(k) number K050137.

Who is the listed applicant for TEMPTOUCH DERMAL THERMOMETER?

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

What is the FDA product code for TEMPTOUCH DERMAL THERMOMETER?

The FDA product code for TEMPTOUCH DERMAL 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 Xilas Medical, 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.

K030829VPT METER

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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