FDA 510(k)

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C

Numéro K : K203332 · 2021-02-25

Date de décision2021-02-25

Code produitFLL

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C is the device name listed in this FDA 510(k) record. The listed applicant is Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K203332. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C?

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Hetaida Technology Co., Ltd.. The 510(k) number is K203332.

When did Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C receive FDA 510(k) clearance?

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C received FDA 510(k) clearance on 2021-02-25, under 510(k) number K203332.

Who is the listed applicant for Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C?

The FDA 510(k) record lists Hetaida Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C?

The FDA product code for Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C is FLL.

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Dispositifs connexes (Code : FLL)

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Source officielle

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