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FDA 510(k)

ri-former Predictive Thermometer

K-Number: K171182 · 2017-10-04

ApplicantRudolf Riester GmbH
Decision Date2017-10-04
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ri-former Predictive Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Rudolf Riester GmbH. It received FDA 510(k) clearance on 2017-10-04 under 510(k) number K171182. 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 ri-former Predictive Thermometer?

ri-former Predictive Thermometer is a medical device that received FDA 510(k) clearance on 2017-10-04. The listed applicant is Rudolf Riester GmbH. The 510(k) number is K171182.

When did ri-former Predictive Thermometer receive FDA 510(k) clearance?

ri-former Predictive Thermometer received FDA 510(k) clearance on 2017-10-04, under 510(k) number K171182.

Who is the listed applicant for ri-former Predictive Thermometer?

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

What is the FDA product code for ri-former Predictive Thermometer?

The FDA product code for ri-former Predictive Thermometer is FLL.

Other records listing Rudolf Riester GmbH as applicant

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.

K190927Oscillometric Blood Pressure MonitorK170538RVS-100 Vital Signs Monitor

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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