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Infrared Thermometer Model MD-H30

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K191570

by Guangzhou Berrcom Medical Device Co., Ltd

Identifiers

510(k) Number
K191570 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 Infrared Thermometer Model MD-H30 is a non-contact infrared thermometer classified under the FDA product code FLL. It measures body temperature by detecting natural thermal radiation emitted from the tympanic membrane or central forehead via a thermopile sensor, providing rapid and precise readings without physical contact.

This device is intended for single-use in general hospital settings and has received FDA 510(k) clearance under the traditional review pathway. Supplied as a reusable instrument, it requires no sterilisation between uses. The Model MD-H30 adheres to MDR compliance and is authorised for use in regulated medical environments, with no MRI safety restrictions specified.

Frequently asked questions

How is the Infrared Thermometer Model MD-H30 intended to be used in a clinical setting, and what body areas does it measure temperature from?

The Model MD-H30 is designed for non-contact temperature measurement by detecting thermal radiation from the tympanic membrane (ear) or the central forehead. This allows for quick, contactless readings, which is particularly useful in general hospital settings where speed and hygiene are critical.

Is the Infrared Thermometer Model MD-H30 meant for single-use or reusable applications, and what does that mean for maintenance?

The device is supplied as a reusable instrument, meaning it is not intended for single-use. Since it does not require sterilization between uses, maintenance involves routine cleaning and calibration to ensure accuracy and functionality over repeated clinical applications.

What regulatory pathways has the Infrared Thermometer Model MD-H30 followed, and what does that imply for its use in different markets?

The device has received FDA 510(k) clearance under the traditional review pathway and complies with MDR (Medical Device Regulation) standards. This means it is authorized for use in the U.S. and EU markets, adhering to their respective regulatory requirements for non-contact infrared thermometers in general hospital settings.

Are there any special storage requirements for the Infrared Thermometer Model MD-H30, and does it have any safety restrictions?

The device does not specify unique storage requirements beyond standard environmental conditions for medical instruments. Additionally, there are no MRI safety restrictions mentioned, so it can be safely used in areas where MRI machines are present.

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: Infrared Thermometer Model MD-H30 (K191570) - FDA 510 (k), Infrared Thermometer Model MD-H30 (K191570) - Innolitics, Infrared Thermometer Model MD-H30 - healthcareequipment.org, Infrared Thermometer Model MD-H30 - BEUDAMED

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangzhou Berrcom Medical Device Co., Ltd
FDA Applicant
Guangzhou Berrcom Medical Device Co., Ltd.

Sources (2)

  • FDA 510(k) K191570 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026