Skip to content

Vitacomm Model #140/141 Esophageal Stethoscope

by Vitacomm, Inc.

510(k) K885347

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK885347 Date30 Jan 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BZT
Device Class
Class II
Regulation
21 CFR Part 868.1920
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vitacomm Model #140/141 Esophageal Stethoscope is an esophageal stethoscope with electrical conductors, classified under FDA regulation 868.1920. This device is designed to auscultate internal thoracic and esophageal sounds, facilitating monitoring during surgical and anesthetic procedures, particularly in anesthesiology.

Supplied as a reusable medical instrument, the device is intended for use in clinical settings where direct auscultation of the esophagus and thoracic cavity is required. It has received FDA 510(k) clearance under the Traditional pathway and is regulated as a Class II device. No specific sterility or MRI safety information is provided in the available data.

Other devices from Vitacomm, Inc.