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Sheridan YSI/ECG Sonatemp

by Sheridan Catheter Corp.

510(k) K861541

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 NumberK861541 Date16 Jun 1986ClearedStatusActive

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  • Withdrawn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)

Full name
Sheridan - Ysi/ECG Sonatemp (Tm)
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, 6 Oct 2026

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

The Sheridan YSI/ECG Sonatemp is an esophageal stethoscope with electrical conductors. It is designed to facilitate both auscultation and temperature monitoring within a clinical setting.

This device is identified by FDA 510(k) number K861541. It is classified under regulation number 868.1920 and falls under the product code BZT.

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