Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR

K-Number: K843071 · 1984-08-24

ApplicantPrimrose Medical, Inc.
Decision Date1984-08-24
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR is the device name listed in this FDA 510(k) record. The listed applicant is Primrose Medical, Inc.. It received FDA 510(k) clearance on 1984-08-24 under 510(k) number K843071. 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 ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR?

ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR is a medical device that received FDA 510(k) clearance on 1984-08-24. The listed applicant is Primrose Medical, Inc.. The 510(k) number is K843071.

When did ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR receive FDA 510(k) clearance?

ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR received FDA 510(k) clearance on 1984-08-24, under 510(k) number K843071.

Who is the listed applicant for ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR?

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

What is the FDA product code for ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR?

The FDA product code for ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR 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 Primrose Medical, 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.

K884715ACHELASIA BALLOON DIALATORK884714BILIARY DIALATORK884711URETHRAL AND URETERAL BALLOON DILATATORSK884713COLONIC BALLOON DIALATORSK884712ESOPHAGEAL AND PYLORIC BALLOON DIALATORSK884709ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)

View all 14 devices →

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.

↑