Digital Thermometer- - BT-308

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193621

Identifiers

510(k) Number: K193621 FDA 510(k)
FDA Product Code: FLL FDA 510(k)
Models / Variants: Model BT-301 FDA 510(k)
BT-302 FDA 510(k)
BT-303 FDA 510(k)
BT-305 FDA 510(k)
BT-306 FDA 510(k)
BT-308 FDA 510(k)
BT-311 FDA 510(k)
BT-318 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)

Digital Thermometer- - BT-308 by Dongguan E-Test Technology Co., Ltd — Class II — FDA_510K — listed in FDA 510(k) — 8 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K193621	Class II	Active

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Manufacturer

Manufacturer: Dongguan E-Test Technology Co., Ltd
FDA Applicant: Dongguan E-Test Technology Co., Ltd.

Sources (1)

FDA 510(k) K193621 24 fields · synced Jun 18, 2026