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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 a medical device manufactured by Stethocloud Pty.Ltd (Clinicloud). It received FDA 510(k) clearance on 2016-06-22 under approval 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. It is manufactured by Stethocloud Pty.Ltd (Clinicloud). The 510(k) number is K161325.

When was CliniCloud Non-contact Thermometer, Model SPL1024 approved by the FDA?

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

What company makes CliniCloud Non-contact Thermometer, Model SPL1024?

CliniCloud Non-contact Thermometer, Model SPL1024 is manufactured by Stethocloud Pty.Ltd (Clinicloud).

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.

Related Clinical Trials

NCT05535738 Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation ACTIVE_NOT_RECRUITING

Other Devices by Stethocloud Pty.Ltd (Clinicloud)

K173448CliniCloud Stethoscope

Related Devices (Code: FLL)

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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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