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FDA 510(k)

Temperature Probe

K-Number: K173194 · 2018-10-10

ApplicantOrantech, Inc.
Decision Date2018-10-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Temperature Probe is the device name listed in this FDA 510(k) record. The listed applicant is Orantech, Inc.. It received FDA 510(k) clearance on 2018-10-10 under 510(k) number K173194. 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 Temperature Probe?

Temperature Probe is a medical device that received FDA 510(k) clearance on 2018-10-10. The listed applicant is Orantech, Inc.. The 510(k) number is K173194.

When did Temperature Probe receive FDA 510(k) clearance?

Temperature Probe received FDA 510(k) clearance on 2018-10-10, under 510(k) number K173194.

Who is the listed applicant for Temperature Probe?

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

What is the FDA product code for Temperature Probe?

The FDA product code for Temperature Probe 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.

NCT07054411Hemoglobin Monitoring in Scoliosis SurgeryCOMPLETEDNCT07756892Continuous Monitoring of Body Temperature in Neonates During Therapeutic HypothermiaNOT_YET_RECRUITING

Other records listing Orantech, Inc. 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.

K182327Patient Cables and Leadwires , Disposable ECG LeadwiresK181270Disposable SpO2 Sensors, Reusable SpO2 SensorsK173197Reusable NIBP CuffK171828ETCO2 Sensor

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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