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Esophageal Stethoscopes With Electrical Conductors

FDA 510(k)

Class II (US FDA 510(k))

510(k) K843071

by Primrose Medical, Inc.

Identifiers

510(k) Number
K843071 FDA 510(k)
FDA Product Code
BZT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1920 FDA 510(k)
Regulation Number
868.1920 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Esophageal Stethoscope With Electrical Conductors is a medical device designed for insertion into the esophagus. It allows clinicians to monitor a patient's heart and breath sounds while simultaneously tracking electrophysiological signals.

This device is classified as a Class 2 medical device under regulation number 868.1920 and has received FDA 510(k) clearance. It is intended for use within the field of anesthesiology.

Frequently asked questions

What is the primary clinical use for this esophageal stethoscope?

This device is designed for insertion into the esophagus during anesthesia procedures. It allows clinicians to simultaneously monitor a patient's heart and breath sounds while tracking electrophysiological signals.

What is the regulatory classification of this device?

This device is classified as a Class 2 medical device under regulation number 868.1920. It has received FDA 510(k) clearance, indicating it has been found substantially equivalent to legally marketed predicate devices.

Which medical specialty is this device intended for?

The device is intended for use within the field of anesthesiology. It is categorized under the Anesthesiology advisory committee, reflecting its specific application in monitoring patients during clinical procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR (K843071) — FDA 510(k ..., Esophageal Stethoscopes W/Elec Conductor - Beudamed, BZT · Stethoscope, Esophageal, With Electrical Conductors

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Primrose Medical, Inc.

Sources (1)

  • FDA 510(k) K843071 24 fields · synced Sep 25, 2026