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Firsttemp Genius

by Intelligent Medical Systems

510(k) K920713

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920713 Date17 Dec 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 28 Sep 2026

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

The Firsttemp Genius is an electronic clinical thermometer, classified as a device class 2. It is a type of thermometer used in clinical settings, specifically in general hospitals.

The Firsttemp Genius is supplied with FDA 510K clearance, with the decision description being substantially equivalent. It has a product code of FLL and is regulated under the classification name Thermometer, Electronic, Clinical, with a review panel of General Hospital. The device has a specific K number, K920713, and is a device from Intelligent Medical Systems.

Other devices from Intelligent Medical Systems

  • First Temp

    Class II

Questions

AI-generated answers, 28 Sep 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 Firsttemp Genius used for?

    The Firsttemp Genius is used in clinical settings, specifically in general hospitals, to measure temperature.

  • Is the Firsttemp Genius supplied sterile?

    The device data does not specify if the Firsttemp Genius is supplied sterile, contact the manufacturer for more information.

  • What is the regulatory classification of the Firsttemp Genius?

    The Firsttemp Genius is classified as a device class 2, with a product code of FLL, and is regulated under the classification name Thermometer, Electronic, Clinical.