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FDA 510(k)

CliniCloud Non-contact Thermometer, Model SPL1024

K-Number: K161325 · 2016-06-22

ApplicantStethocloud Pty.Ltd (Clinicloud)
Decision Date2016-06-22
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CliniCloud Non-contact Thermometer, Model SPL1024 is the device name listed in this FDA 510(k) record. The listed applicant is Stethocloud Pty.Ltd (Clinicloud). It received FDA 510(k) clearance on 2016-06-22 under 510(k) number K161325. 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 CliniCloud Non-contact Thermometer, Model SPL1024?

CliniCloud Non-contact Thermometer, Model SPL1024 is a medical device that received FDA 510(k) clearance on 2016-06-22. The listed applicant is Stethocloud Pty.Ltd (Clinicloud). The 510(k) number is K161325.

When did CliniCloud Non-contact Thermometer, Model SPL1024 receive FDA 510(k) clearance?

CliniCloud Non-contact Thermometer, Model SPL1024 received FDA 510(k) clearance on 2016-06-22, under 510(k) number K161325.

Who is the listed applicant for CliniCloud Non-contact Thermometer, Model SPL1024?

The FDA 510(k) record lists Stethocloud Pty.Ltd (Clinicloud) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CliniCloud Non-contact Thermometer, Model SPL1024?

The FDA product code for CliniCloud Non-contact Thermometer, Model SPL1024 is FLL.

Other records listing Stethocloud Pty.Ltd (Clinicloud) 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.

K173448CliniCloud Stethoscope

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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