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FDA 510(k)

LIFESOUND ESOPHAGEAL STETHOSCOPE

K-Number: K811928 · 1981-07-28

ApplicantBiomedical Concepts, Inc.
Decision Date1981-07-28
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFESOUND ESOPHAGEAL STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Concepts, Inc.. It received FDA 510(k) clearance on 1981-07-28 under 510(k) number K811928. 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 LIFESOUND ESOPHAGEAL STETHOSCOPE?

LIFESOUND ESOPHAGEAL STETHOSCOPE is a medical device that received FDA 510(k) clearance on 1981-07-28. The listed applicant is Biomedical Concepts, Inc.. The 510(k) number is K811928.

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

LIFESOUND ESOPHAGEAL STETHOSCOPE received FDA 510(k) clearance on 1981-07-28, under 510(k) number K811928.

Who is the listed applicant for LIFESOUND ESOPHAGEAL STETHOSCOPE?

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

What is the FDA product code for LIFESOUND ESOPHAGEAL STETHOSCOPE?

The FDA product code for LIFESOUND ESOPHAGEAL STETHOSCOPE is BZT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biomedical Concepts, 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.

K864858LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTORK844804LIFESOUND - ELECTRONIC STETHOSCOPE

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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