Cleared Traditional

ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE

K912742 · Spacelabs, Inc. · General Hospital

Apr 1992

Decision

304d

Days

Class 2

Risk

About This 510(k) Submission

K912742 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on April 20, 1992, 304 days after receiving the submission on June 21, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K912742 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 1991
Decision Date	April 20, 1992
Days to Decision	304 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

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.