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FDA 510(k)

DISPOSABLE ESOPHAGEAL STETHOSCOPE

K-Number: K973839 · 1998-03-19

ApplicantCatheter Research, Inc.
Decision Date1998-03-19
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ESOPHAGEAL STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Research, Inc.. It received FDA 510(k) clearance on 1998-03-19 under 510(k) number K973839. 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 DISPOSABLE ESOPHAGEAL STETHOSCOPE?

DISPOSABLE ESOPHAGEAL STETHOSCOPE is a medical device that received FDA 510(k) clearance on 1998-03-19. The listed applicant is Catheter Research, Inc.. The 510(k) number is K973839.

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

DISPOSABLE ESOPHAGEAL STETHOSCOPE received FDA 510(k) clearance on 1998-03-19, under 510(k) number K973839.

Who is the listed applicant for DISPOSABLE ESOPHAGEAL STETHOSCOPE?

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

What is the FDA product code for DISPOSABLE ESOPHAGEAL STETHOSCOPE?

The FDA product code for DISPOSABLE ESOPHAGEAL STETHOSCOPE is BZT.

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Other records listing Catheter Research, Inc. as applicant

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.

K123258THE ADVANCE CATHETER FOR HSG AND SISK120154INTRAUTERINE INSEMINATION (IUI) CATHETERK032835H/S CATHETER SETK020292UTERINE INJECTORK974357UTERINE MANIPULATOR/INJECTORK951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING

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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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