Fora Comfortscan Ear Thermometer, Models Td-1261a +1 more model

FDA 510(k)

Class II (US FDA 510(k))

510(k) K081445

Identifiers

510(k) Number: K081445 FDA 510(k)
FDA Product Code: FLL FDA 510(k)
Models / Variants: Fora Comfortscan Ear Thermometer, Models Td-1261a FDA 510(k)
Td-1261b 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)

Fora Comfortscan Ear Thermometer, Models Td-1261a +1 more model by Taidoc Technology Corporation — Class II — FDA_510K — listed in FDA 510(k) — 2 models

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	K081445	Class II	Active

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Manufacturer

Manufacturer: Taidoc Technology Corporation

Sources (1)

FDA 510(k) K081445 24 fields · synced Jun 18, 2026