Class Class II

Digital Thermometer, Model: DT007, DT008 (K214077)

K214077 2023-01-20 Traditional
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Description

Digital Thermometer, Model: DT007, DT008 by Guangzhou Berrcom Medical Device Co., Ltd., an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK214077
Clearance Date2023-01-20
Clearance TypeTraditional
Product CodeFLL
Regulation Number880.2910

Categories

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Predicate lineage for K214077

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Digital Thermometer, Model: DT007, DT008 (K214077) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K203731DT100 Digital ThermometerSmart Technology Co., Ltd.2021
K163603Digital ThermometerGuangzhou Jinxinbao Electronic Co.,...2017

Trace the full predicate network for K214077

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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