Disposable Temperature Probe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182755

by Shenzhen Caremed Medical Technology Co., Ltd.

Identifiers

510(k) Number: K182755 FDA 510(k)
FDA Product Code: FLL FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 880.2910 FDA 510(k)
Regulation Number: 880.2910 FDA 510(k)
Advisory Committee: General Hospital FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Disposable Temperature Probe is a medical device designed for measuring body temperature. It is intended for use in clinical settings to provide accurate and reliable temperature readings.

The probe is supplied sterile and is intended for single-use to ensure hygiene and prevent cross-contamination. It is compatible with various monitoring systems and is regulated under FDA 510(k) authorization. Proper storage conditions should be maintained to ensure device integrity.

Frequently asked questions

What is the intended use of the Disposable Temperature Probe?

The Disposable Temperature Probe is a medical device designed for measuring body temperature in clinical settings to provide accurate and reliable readings.

Is the probe sterile and intended for single use?

Yes, the probe is supplied sterile and is intended for single use to ensure hygiene and prevent cross-contamination.

How should the Disposable Temperature Probe be stored?

Proper storage conditions should be maintained to ensure device integrity.

What is the regulatory status of the device?

The device is regulated under FDA 510(k) authorization.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Shenzhen Caremed Medical Technology Co., Ltd, Temperature probe - Shenzhen Caremed Medical Technology Co., Ltd., Shenzhen Caremed Medical Technology Co., Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K182755	Class II	Active

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Manufacturer

Manufacturer: Shenzhen Caremed Medical Technology Co., Ltd.

Sources (1)

FDA 510(k) K182755 24 fields · synced Sep 19, 2026