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Digital Fashion Thermometer

by Kanada Manufacturing Co., Ltd. 510(k)

Active United States

510(k) K854706

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK854706 Date16 Jan 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Digital Fashion Thermeter is an electronic clinical thermometer designed for measuring body temperature. It is intended for general hospital use and provides digital temperature readings.

The device is supplied by Kanada Manufacturing Co., Ltd. and has FDA 510(k) clearance with product code FLL. It is classified as a thermometer, electronic, clinical, and was reviewed by the General Hospital advisory committee. The device received FDA clearance on January 16, 1986.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Digital Fashion Thermometer used for?

    The Digital Fashion Thermometer is an electronic clinical thermometer designed for measuring body temperature in general hospital settings. It provides digital temperature readings for clinical assessment.

  • How is the Digital Fashion Thermometer supplied?

    The device is supplied by Kanada Manufacturing Co., Ltd. It is classified as a thermometer, electronic, clinical, with FDA 510(k) clearance and product code FLL.

  • Is the Digital Fashion Thermometer single-use or reusable?

    The device description does not specify whether it is single-use or reusable. As an electronic clinical thermometer, it is likely designed for multiple uses, but this should be confirmed with the manufacturer's instructions for use.

  • What is the regulatory status of the Digital Fashion Thermometer?

    The Digital Fashion Thermometer has FDA 510(k) clearance with product code FLL. It was reviewed by the General Hospital advisory committee and received FDA clearance on January 16, 1986, with a decision code of SESE (Substantially Equivalent).