FDA 510(k)

ESOPHAGEAL STETHOSCOPES

K-Number: K843070 · 1984-08-24

Decision Date1984-08-24

Product CodeBZW

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL STETHOSCOPES 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 K843070. 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 STETHOSCOPES?

ESOPHAGEAL STETHOSCOPES 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 K843070.

When did ESOPHAGEAL STETHOSCOPES receive FDA 510(k) clearance?

ESOPHAGEAL STETHOSCOPES received FDA 510(k) clearance on 1984-08-24, under 510(k) number K843070.

Who is the listed applicant for ESOPHAGEAL STETHOSCOPES?

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?

The FDA product code for ESOPHAGEAL STETHOSCOPES 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Primrose Medical, Inc. as applicant

K884715ACHELASIA BALLOON DIALATOR K884714BILIARY DIALATOR K884711URETHRAL AND URETERAL BALLOON DILATATORS K884713COLONIC BALLOON DIALATORS K884712ESOPHAGEAL AND PYLORIC BALLOON DIALATORS K884709ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)

View all 14 devices →

Related Devices (Code: BZW)

K874519MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSORMon-A-Therm, Inc.K860558ESOPHAGEAL STETHOSCOPESharn, Inc.K844444ESOPHAGEAL STETHOSCOPEMedical Parameters, Inc.K842865ESOPHAGEAL STETHOSCOPEInmed Corp.K841574QUAZAR ESOPHAGEAL STETHOSCOPEAxiom Medical, Inc.K830329ESOPHAGEAL STETHOSCOPEScience Development Corp.

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.