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FDA 510(k)

AViTA Radar Thermo NT16 Series IR Thermometer

K-Number: K172427 · 2018-04-19

ApplicantAvita Corporation
Decision Date2018-04-19
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AViTA Radar Thermo NT16 Series IR 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 2018-04-19 under 510(k) number K172427. 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 Radar Thermo NT16 Series IR Thermometer?

AViTA Radar Thermo NT16 Series IR Thermometer is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Avita Corporation. The 510(k) number is K172427.

When did AViTA Radar Thermo NT16 Series IR Thermometer receive FDA 510(k) clearance?

AViTA Radar Thermo NT16 Series IR Thermometer received FDA 510(k) clearance on 2018-04-19, under 510(k) number K172427.

Who is the listed applicant for AViTA Radar Thermo NT16 Series IR 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 Radar Thermo NT16 Series IR Thermometer?

The FDA product code for AViTA Radar Thermo NT16 Series IR 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

View on FDA Database →

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

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