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FDA 510(k)

TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER

K-Number: K862548 · 1986-10-22

ApplicantLawrence Medical Systems, Inc.
Decision Date1986-10-22
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Lawrence Medical Systems, Inc.. It received FDA 510(k) clearance on 1986-10-22 under 510(k) number K862548. 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 TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER?

TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER is a medical device that received FDA 510(k) clearance on 1986-10-22. The listed applicant is Lawrence Medical Systems, Inc.. The 510(k) number is K862548.

When did TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER receive FDA 510(k) clearance?

TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER received FDA 510(k) clearance on 1986-10-22, under 510(k) number K862548.

Who is the listed applicant for TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER?

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

What is the FDA product code for TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER?

The FDA product code for TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER 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.

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 Lawrence Medical Systems, 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.

K874492LAWRENCE L4000 REFLECTANCE PULSE OXIMETERK874885LAWRENCE L3000 CARDIAC OUTPUT MONITORK851426ACCUCOM CARDIAC OUTPUT MONITOR

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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