Cleared Traditional

DIGITAL THERMOMETER KITS

K905025 · Abco Dealers, Inc. · General Hospital

Feb 1991

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K905025 is an FDA 510(k) clearance for the DIGITAL THERMOMETER KITS, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Abco Dealers, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 7, 1991, 92 days after receiving the submission on November 7, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K905025 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 1990
Decision Date	February 07, 1991
Days to Decision	92 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—

Device Classification

Product Code	FLL — Continuous Measurement Thermometer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.2910
Definition	A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.