Cleared Traditional

K933832 - ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR
(FDA 510(k) Clearance)

K933832 · Electromedics, Inc. · General Hospital

Jan 1994

Decision

176d

Days

Class 2

Risk

K933832 is an FDA 510(k) clearance for the ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on January 28, 1994, 176 days after receiving the submission on August 5, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K933832 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 1993
Decision Date	January 28, 1994
Days to Decision	176 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.