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FDA 510(k)

TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE

K-Number: K904943 · 1991-04-26

ApplicantArzco Medical Electronics, Inc.
Decision Date1991-04-26
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Arzco Medical Electronics, Inc.. It received FDA 510(k) clearance on 1991-04-26 under 510(k) number K904943. 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 TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE?

TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE is a medical device that received FDA 510(k) clearance on 1991-04-26. The listed applicant is Arzco Medical Electronics, Inc.. The 510(k) number is K904943.

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

TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE received FDA 510(k) clearance on 1991-04-26, under 510(k) number K904943.

Who is the listed applicant for TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE?

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

What is the FDA product code for TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE?

The FDA product code for TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE is BZT.

Related Clinical Trials

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Other records listing Arzco Medical Electronics, 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.

K905831ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATHK903136ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER

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

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

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