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FDA 510(k)

Radius T wearable thermometer

K-Number: K203215 · 2021-06-11

ApplicantMasimo Corporation
Decision Date2021-06-11
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Radius T wearable thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2021-06-11 under 510(k) number K203215. 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 Radius T wearable thermometer?

Radius T wearable thermometer is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Masimo Corporation. The 510(k) number is K203215.

When did Radius T wearable thermometer receive FDA 510(k) clearance?

Radius T wearable thermometer received FDA 510(k) clearance on 2021-06-11, under 510(k) number K203215.

Who is the listed applicant for Radius T wearable thermometer?

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

What is the FDA product code for Radius T wearable thermometer?

The FDA product code for Radius T wearable thermometer is FLL.

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Other records listing Masimo Corporation 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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