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FDA 510(k)

MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO

K-Number: K823743 · 1983-01-18

ApplicantY
Decision Date1983-01-18
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO is the device name listed in this FDA 510(k) record. The listed applicant is Y. It received FDA 510(k) clearance on 1983-01-18 under 510(k) number K823743. 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 MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO?

MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO is a medical device that received FDA 510(k) clearance on 1983-01-18. The listed applicant is Y. The 510(k) number is K823743.

When did MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO receive FDA 510(k) clearance?

MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO received FDA 510(k) clearance on 1983-01-18, under 510(k) number K823743.

Who is the listed applicant for MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO?

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

What is the FDA product code for MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO?

The FDA product code for MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO is BZT.

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Other records listing Y as applicant

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K955846MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETERK960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSK953225IVAC BALL VALCE ADMIN. SETSK934095IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETSK940897IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SETK931550EZ ADMINISTRATION SET

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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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