Cleared Traditional

MYOCARDIAL PROBE THERMOMETER CODE 64000

K893418 · Dlp, Inc. · General Hospital

Sep 1989

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K893418 is an FDA 510(k) clearance for the MYOCARDIAL PROBE THERMOMETER CODE 64000, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on September 5, 1989, 126 days after receiving the submission on May 2, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K893418 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 1989
Decision Date	September 05, 1989
Days to Decision	126 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.