Fudakang Bluetooth Digital Thermometer BT-A41CN-BT
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160308 FDA 510(k)
- FDA Product Code
- FLL 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)
The Fudakang Bluetooth Digital Thermometer BT-A41CN-BT is a non-invasive digital thermometer designed for oral, rectal, and axillary temperature measurement. It employs Bluetooth connectivity to wirelessly transmit readings to compatible devices, enhancing convenience and accuracy in clinical and home settings.
This device is intended for single-use or reusable applications in general hospital environments, as classified under product code FLL. Supplied sterile or non-sterile based on user preparation, it requires no special storage conditions beyond standard room temperature. The thermometer holds FDA 510(k) clearance under Special Review (K160308) and is intended for use in regulated healthcare settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160308 | Class II | Active |
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Manufacturer
- Manufacturer
- Fudakang Industrial Co., Ltd.
Sources (1)
- FDA 510(k) K160308 24 fields · synced Sep 19, 2026