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FDA 510(k)

ESOPHAGEAL STETH. TEMP. SENSOR

K-Number: K771411 · 1977-09-23

ApplicantLabarge, Inc.
Decision Date1977-09-23
Product CodeBZW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL STETH. TEMP. SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Labarge, Inc.. It received FDA 510(k) clearance on 1977-09-23 under 510(k) number K771411. The device is classified under product code BZW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESOPHAGEAL STETH. TEMP. SENSOR?

ESOPHAGEAL STETH. TEMP. SENSOR is a medical device that received FDA 510(k) clearance on 1977-09-23. The listed applicant is Labarge, Inc.. The 510(k) number is K771411.

When did ESOPHAGEAL STETH. TEMP. SENSOR receive FDA 510(k) clearance?

ESOPHAGEAL STETH. TEMP. SENSOR received FDA 510(k) clearance on 1977-09-23, under 510(k) number K771411.

Who is the listed applicant for ESOPHAGEAL STETH. TEMP. SENSOR?

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

What is the FDA product code for ESOPHAGEAL STETH. TEMP. SENSOR?

The FDA product code for ESOPHAGEAL STETH. TEMP. SENSOR is BZW.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Labarge, 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.

K792037NON-A-THERMK771520ESOPHAGEAL STETHOSCOPEK760720MON-A-THERM TEMPARATURE MONITOR SYS

Related Devices (Code: BZW)

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.

K874519MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSORMon-A-Therm, Inc.K860558ESOPHAGEAL STETHOSCOPESharn, Inc.K844444ESOPHAGEAL STETHOSCOPEMedical Parameters, Inc.K843070ESOPHAGEAL STETHOSCOPESPrimrose Medical, Inc.K842865ESOPHAGEAL STETHOSCOPEInmed Corp.K841574QUAZAR ESOPHAGEAL STETHOSCOPEAxiom Medical, Inc.

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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