Esophageal Stethoscope

FDA 510(k) K860558 · Sharn, Inc.

Substantially Equivalent

510(k) numberK860558

Submission

Device name
Esophageal Stethoscope
Applicant
Sharn, Inc.
Tampa, FL, US
Received
February 14, 1986
Decision date
April 1, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BZW – Stethoscope, Esophageal
Device class
Class I (low risk)
Regulation
21 CFR 868.1910
Specialty
Anesthesiology

Other 510(k)s with product code BZW

510(k)DeviceApplicantDecision
K874519Modified Esophageal Stethoscope/Temperature SensorBZW · Traditional Mon-A-Therm, Inc.01/29/1988SE
K844444Esophageal StethoscopeBZW · Traditional Medical Parameters, Inc.01/10/1985SE
K843070Esophageal StethoscopesBZW · Traditional Primrose Medical, Inc.08/24/1984SE
K842865Esophageal StethoscopeBZW · Traditional Inmed Corp.08/15/1984SE
K841574Quazar Esophageal StethoscopeBZW · Traditional Axiom Medical, Inc.08/15/1984SE
K830329Esophageal StethoscopeBZW · Traditional Science Development Corp.03/11/1983SE
K830218Sheridan/Esophageal StethoscopeBZW · Traditional Sheridan Catheter Corp.03/09/1983SE
K823703Esophageal StethoscopeBZW · Traditional Rsp, Inc.01/07/1983SE
K823126Model SA-1 Stethoscope Audio AmplifierBZW · Traditional Electromedics, Inc.11/16/1982SE
K800463Esophageal StethescopeBZW · Traditional Medical Components, Inc.03/10/1980SE

More from Medical Components, Inc.

510(k)DeviceDecision
K070596Topical ApplicatorCCT · Traditional 06/21/2007SE
K932305Vila-Cooke(Tm) Anesthesia PillowCCX · Traditional 10/05/1993SE
K894032Evac-TubeCAO · Traditional 08/31/1989SE

Questions and answers

When was Esophageal Stethoscope cleared by the FDA?

Esophageal Stethoscope (K860558) received a 510(k) decision of Substantially Equivalent on April 1, 1986, 46 days after the submission was received.

What is the product code of K860558?

The FDA product code is BZW – Stethoscope, Esophageal, a Class I (low risk) device regulated under 21 CFR 868.1910.