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FDA 510(k)

SteadyTemp

K-Number: K233280 · 2024-06-21

ApplicantSteadysense GmbH
Decision Date2024-06-21
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SteadyTemp is the device name listed in this FDA 510(k) record. The listed applicant is Steadysense GmbH. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K233280. 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 SteadyTemp?

SteadyTemp is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Steadysense GmbH. The 510(k) number is K233280.

When did SteadyTemp receive FDA 510(k) clearance?

SteadyTemp received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233280.

Who is the listed applicant for SteadyTemp?

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

What is the FDA product code for SteadyTemp?

The FDA product code for SteadyTemp 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.

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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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