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FDA 510(k)

ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR

K-Number: K854212 · 1986-01-03

ApplicantRespiratory Support Products, Inc.
Decision Date1986-01-03
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Support Products, Inc.. It received FDA 510(k) clearance on 1986-01-03 under 510(k) number K854212. 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 ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR?

ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR is a medical device that received FDA 510(k) clearance on 1986-01-03. The listed applicant is Respiratory Support Products, Inc.. The 510(k) number is K854212.

When did ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR receive FDA 510(k) clearance?

ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR received FDA 510(k) clearance on 1986-01-03, under 510(k) number K854212.

Who is the listed applicant for ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR?

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

What is the FDA product code for ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR?

The FDA product code for ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR is BZT.

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Other records listing Respiratory Support Products, 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.

K983862CLOUD 1 HUMIDIFICATION SYSTEMK921190ADAP-TEMP TEMPERATURE SENSOR ADAPTERK920469MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIEK921510GAS SAMPLING KIT MODIFICATIONK913082BI-TEMP TEMPERATURE MONITOR,MODEL TM-300DK912280BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D

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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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