MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR— 510(k) K874519

Name: FDA 510(k) clearance K874519
Creator: U.S. Food and Drug Administration
Published: 1988-01-29

Substantially Equivalent

Mon-A-Therm, Inc.

FDA 510(k) clearance K874519 for MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR, Substantially Equivalent on 1988-01-29. Applicant: Mon-A-Therm, Inc.. Device class: 1.

Clearance details

Applicant: Mon-A-Therm, Inc.
Product code: Code BZW
Device class: Class 1
Regulation: 21 CFR 868.1910
Advisory panel: Anesthesiology
Date received: 1987-11-02
Decision date: 1988-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.