Product Code: BZW FDA class 1 21 CFR 868.1910

Stethoscope, Esophageal

Anesthesiology

The Stethoscope, Esophageal is a probe inserted into the esophagus to allow close auscultation of heart and lung sounds during general anesthesia, where a conventional external stethoscope cannot be used. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BZW, regulated under 21 CFR 868.1910 in the Anesthesiology specialty.

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FEI Numbers

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Basic Information

Product Code: BZW
Device Class: FDA class 1
Regulation Number: 868.1910
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K874519	MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR	Jan 29, 1988	Substantially Equivalent	Mon-A-Therm, Inc.
K860558	ESOPHAGEAL STETHOSCOPE	Apr 01, 1986	Substantially Equivalent	Sharn, Inc.
K844444	ESOPHAGEAL STETHOSCOPE	Jan 10, 1985	Substantially Equivalent	Medical Parameters, Inc.
K843070	ESOPHAGEAL STETHOSCOPES	Aug 24, 1984	Substantially Equivalent	Primrose Medical, Inc.
K842865	ESOPHAGEAL STETHOSCOPE	Aug 15, 1984	Substantially Equivalent	Inmed Corp.
K841574	QUAZAR ESOPHAGEAL STETHOSCOPE	Aug 15, 1984	Substantially Equivalent	Axiom Medical, Inc.
K830329	ESOPHAGEAL STETHOSCOPE	Mar 11, 1983	Substantially Equivalent	Science Development Corp.
K830218	SHERIDAN/ESOPHAGEAL STETHOSCOPE	Mar 09, 1983	Substantially Equivalent	Sheridan Catheter Corp.
K823703	ESOPHAGEAL STETHOSCOPE	Jan 07, 1983	Substantially Equivalent	Rsp, Inc.
K823126	MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER	Nov 16, 1982	Substantially Equivalent	Electromedics, Inc.
K800463	ESOPHAGEAL STETHESCOPE	Mar 10, 1980	Substantially Equivalent	Medical Components, Inc.
K790523	ARGYLE ESOPHAGEAL STETHOSCOPE	Mar 27, 1979	Substantially Equivalent	Sherwood Medical Industries
K771411	ESOPHAGEAL STETH. TEMP. SENSOR	Sep 23, 1977	Substantially Equivalent	Labarge, Inc.