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Talking Clinical Electronic Thermometer (Dx6623b +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K073366

by Shenzhen Dongdixin Technology Co., Ltd.

Identifiers

510(k) Number
K073366 FDA 510(k)
FDA Product Code
FLL FDA 510(k)
Models / Variants
Dx6623b FDA 510(k)
Dt1031 FDA 510(k)
Dt1041 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)

Talking Clinical Electronic Thermometer (Dx6623b +2 more) by Shenzhen Dongdixin Technology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 3 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K073366 24 fields · synced Jun 18, 2026