FDA 510(k)

ESOPHAGEAL STETHESCOPE

K-Number: K800463 · 1980-03-10

Decision Date1980-03-10

Product CodeBZW

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL STETHESCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 1980-03-10 under 510(k) number K800463. The device is classified under product code BZW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESOPHAGEAL STETHESCOPE?

ESOPHAGEAL STETHESCOPE is a medical device that received FDA 510(k) clearance on 1980-03-10. The listed applicant is Medical Components, Inc.. The 510(k) number is K800463.

When did ESOPHAGEAL STETHESCOPE receive FDA 510(k) clearance?

ESOPHAGEAL STETHESCOPE received FDA 510(k) clearance on 1980-03-10, under 510(k) number K800463.

Who is the listed applicant for ESOPHAGEAL STETHESCOPE?

The FDA 510(k) record lists Medical Components, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESOPHAGEAL STETHESCOPE?

The FDA product code for ESOPHAGEAL STETHESCOPE is BZW.

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Related Devices (Code: BZW)

K874519MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSORMon-A-Therm, Inc.K860558ESOPHAGEAL STETHOSCOPESharn, Inc.K844444ESOPHAGEAL STETHOSCOPEMedical Parameters, Inc.K843070ESOPHAGEAL STETHOSCOPESPrimrose Medical, Inc.K842865ESOPHAGEAL STETHOSCOPEInmed Corp.K841574QUAZAR ESOPHAGEAL STETHOSCOPEAxiom Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.