Cleared Traditional

K874568 - HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
(FDA 510(k) Clearance)

K874568 · Mallinckrodt Critical Care · General Hospital

Jan 1988

Decision

62d

Days

Class 2

Risk

K874568 is an FDA 510(k) clearance for the HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Mallinckrodt Critical Care (Argyle, US). The FDA issued a Cleared decision on January 6, 1988, 62 days after receiving the submission on November 5, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K874568 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 1987
Decision Date	January 06, 1988
Days to Decision	62 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.