Infrared Thermometer - AOJ-20T

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221039

by Shenzhen AOJ Medical Technology Co., Ltd.

Identifiers

510(k) Number: K221039 FDA 510(k)
FDA Product Code: FLL FDA 510(k)
Models / Variants: AOJ-20A FDA 510(k)
AOJ-20B FDA 510(k)
AOJ-20C FDA 510(k)
AOJ-20D FDA 510(k)
AOJ-20E FDA 510(k)
AOJ-20F FDA 510(k)
AOJ-20H FDA 510(k)
AOJ-20M FDA 510(k)
AOJ-20T FDA 510(k)
AOJ-20R FDA 510(k)
AOJ-20Y 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)

Infrared Thermometer - AOJ-20T by Shenzhen AOJ Medical Technology Co., Ltd. — Class II — listed in FDA 510(k) — 11 models — regulatory data on deviCERTS

Authorization Coverage (0 countries)

Regulatory Authorizations

No authorizations listed.

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Manufacturer

Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.

Sources (1)

FDA 510(k) K221039 24 fields · synced Oct 7, 2026