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FDA 510(k)

LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR

K-Number: K864858 · 1987-03-10

ApplicantBiomedical Concepts, Inc.
Decision Date1987-03-10
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR 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 1987-03-10 under 510(k) number K864858. 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(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR?

LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR is a medical device that received FDA 510(k) clearance on 1987-03-10. The listed applicant is Biomedical Concepts, Inc.. The 510(k) number is K864858.

When did LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR receive FDA 510(k) clearance?

LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR received FDA 510(k) clearance on 1987-03-10, under 510(k) number K864858.

Who is the listed applicant for LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR?

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(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR?

The FDA product code for LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR 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.

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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.

K844804LIFESOUND - ELECTRONIC STETHOSCOPEK811928LIFESOUND ESOPHAGEAL 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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