ESOPHAGEAL STETHOSCOPE— 510(k) K860558

Substantially Equivalent

Sharn, Inc.

FDA 510(k) clearance K860558 for ESOPHAGEAL STETHOSCOPE, Substantially Equivalent on 1986-04-01. Applicant: Sharn, Inc.. Device class: 1.

Clearance details

Applicant: Sharn, Inc.
Product code: Code BZW
Device class: Class 1
Regulation: 21 CFR 868.1910
Advisory panel: Anesthesiology
Date received: 1986-02-14
Decision date: 1986-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZW

K874519 — MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR1988-01-29
K844444 — ESOPHAGEAL STETHOSCOPE1985-01-10
K843070 — ESOPHAGEAL STETHOSCOPES1984-08-24
K841574 — QUAZAR ESOPHAGEAL STETHOSCOPE1984-08-15
K842865 — ESOPHAGEAL STETHOSCOPE1984-08-15

More clearances from Sharn, Inc.

K070596 — TOPICAL APPLICATOR2007-06-21
K932305 — VILA-COOKE(TM) ANESTHESIA PILLOW1993-10-05
K894032 — EVAC-TUBE1989-08-31

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