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FDA 510(k)

VITACOMM 100 ESOPHAGEAL STETHOSCOPE

K-Number: K842309 · 1984-06-22

ApplicantVitacomm, Inc.
Decision Date1984-06-22
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VITACOMM 100 ESOPHAGEAL STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Vitacomm, Inc.. It received FDA 510(k) clearance on 1984-06-22 under 510(k) number K842309. 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 VITACOMM 100 ESOPHAGEAL STETHOSCOPE?

VITACOMM 100 ESOPHAGEAL STETHOSCOPE is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Vitacomm, Inc.. The 510(k) number is K842309.

When did VITACOMM 100 ESOPHAGEAL STETHOSCOPE receive FDA 510(k) clearance?

VITACOMM 100 ESOPHAGEAL STETHOSCOPE received FDA 510(k) clearance on 1984-06-22, under 510(k) number K842309.

Who is the listed applicant for VITACOMM 100 ESOPHAGEAL STETHOSCOPE?

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

What is the FDA product code for VITACOMM 100 ESOPHAGEAL STETHOSCOPE?

The FDA product code for VITACOMM 100 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.

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Other records listing Vitacomm, 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.

K885347VITACOMM MODEL #140/141 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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