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FDA 510(k)

ESOPHAGEAL STETHOSCOPE

K-Number: K982193 · 1998-09-01

ApplicantShore Medical, Inc.
Decision Date1998-09-01
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Shore Medical, Inc.. It received FDA 510(k) clearance on 1998-09-01 under 510(k) number K982193. The device is classified under product code BZT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESOPHAGEAL STETHOSCOPE?

ESOPHAGEAL STETHOSCOPE is a medical device that received FDA 510(k) clearance on 1998-09-01. The listed applicant is Shore Medical, Inc.. The 510(k) number is K982193.

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

ESOPHAGEAL STETHOSCOPE received FDA 510(k) clearance on 1998-09-01, under 510(k) number K982193.

Who is the listed applicant for ESOPHAGEAL STETHOSCOPE?

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

What is the FDA product code for ESOPHAGEAL STETHOSCOPE?

The FDA product code for ESOPHAGEAL STETHOSCOPE is BZT.

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Related Devices (Code: BZT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251025Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)Covidien, LLCK193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 FrenchDeroyal Industries, Inc.K111050ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FRStarboard Medical, LLCK092716ESOPHAGEAL STETHOSCOPETruer Medical, Inc.K072621ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSORCincinnati Sub-Zero Products, Inc.K062020LIFESOUND ESOPHAGEAL STETHOSCOPENovamed, LLC

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.

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