Cleared Traditional

ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR

K072621 · Cincinnati Sub-Zero Products, Inc. · Anesthesiology
Dec 2007
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K072621 is an FDA 510(k) clearance for the ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, a Stethoscope, Esophageal, With Electrical Conductors (Class II — Special Controls, product code BZT), submitted by Cincinnati Sub-Zero Products, Inc. (Sharonville, US). The FDA issued a Cleared decision on December 13, 2007, 87 days after receiving the submission on September 17, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1920.

Submission Details

510(k) Number K072621 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2007
Decision Date December 13, 2007
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZT — Stethoscope, Esophageal, With Electrical Conductors
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1920

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