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FDA 510(k)

STETHOSCOPE WITH TEMPERATURE SENSOR

K-Number: K791190 · 1979-07-06

ApplicantNational Catheter Co. Div. Mallinckrodt
Decision Date1979-07-06
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STETHOSCOPE WITH TEMPERATURE SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is National Catheter Co. Div. Mallinckrodt. It received FDA 510(k) clearance on 1979-07-06 under 510(k) number K791190. 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 STETHOSCOPE WITH TEMPERATURE SENSOR?

STETHOSCOPE WITH TEMPERATURE SENSOR is a medical device that received FDA 510(k) clearance on 1979-07-06. The listed applicant is National Catheter Co. Div. Mallinckrodt. The 510(k) number is K791190.

When did STETHOSCOPE WITH TEMPERATURE SENSOR receive FDA 510(k) clearance?

STETHOSCOPE WITH TEMPERATURE SENSOR received FDA 510(k) clearance on 1979-07-06, under 510(k) number K791190.

Who is the listed applicant for STETHOSCOPE WITH TEMPERATURE SENSOR?

The FDA 510(k) record lists National Catheter Co. Div. Mallinckrodt as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STETHOSCOPE WITH TEMPERATURE SENSOR?

The FDA product code for STETHOSCOPE WITH TEMPERATURE SENSOR is BZT.

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Other records listing National Catheter Co. Div. Mallinckrodt 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.

K802918ANTHRON CATHETER SETK802505DOUBLE LUMEN TRACHEAL TUBEK810321REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)K801924HI-LO TEMP GEN. PURPOSE TEMP. PROBEK801005MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)K781665TUBE, LEATHERMAN/IMBRUCE

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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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