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FDA 510(k)

AVITA TSO/TS1 INFRARED EAR THERMOMETER

K-Number: K002182 · 2000-12-29

ApplicantAvita Corporation
Decision Date2000-12-29
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AVITA TSO/TS1 INFRARED EAR THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Avita Corporation. It received FDA 510(k) clearance on 2000-12-29 under 510(k) number K002182. 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 AVITA TSO/TS1 INFRARED EAR THERMOMETER?

AVITA TSO/TS1 INFRARED EAR THERMOMETER is a medical device that received FDA 510(k) clearance on 2000-12-29. The listed applicant is Avita Corporation. The 510(k) number is K002182.

When did AVITA TSO/TS1 INFRARED EAR THERMOMETER receive FDA 510(k) clearance?

AVITA TSO/TS1 INFRARED EAR THERMOMETER received FDA 510(k) clearance on 2000-12-29, under 510(k) number K002182.

Who is the listed applicant for AVITA TSO/TS1 INFRARED EAR THERMOMETER?

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

What is the FDA product code for AVITA TSO/TS1 INFRARED EAR THERMOMETER?

The FDA product code for AVITA TSO/TS1 INFRARED EAR THERMOMETER is FLL.

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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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