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FDA 510(k)

Tyto Thermometer

K-Number: K190242 · 2019-03-27

ApplicantTyto Care , Ltd.
Decision Date2019-03-27
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Tyto Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Tyto Care , Ltd.. It received FDA 510(k) clearance on 2019-03-27 under 510(k) number K190242. 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 Tyto Thermometer?

Tyto Thermometer is a medical device that received FDA 510(k) clearance on 2019-03-27. The listed applicant is Tyto Care , Ltd.. The 510(k) number is K190242.

When did Tyto Thermometer receive FDA 510(k) clearance?

Tyto Thermometer received FDA 510(k) clearance on 2019-03-27, under 510(k) number K190242.

Who is the listed applicant for Tyto Thermometer?

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

What is the FDA product code for Tyto Thermometer?

The FDA product code for Tyto Thermometer is FLL.

Other records listing Tyto Care , Ltd. as applicant

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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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