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)

DISPOSABLE ESOPHAGEAL STETHOSCOPE

K-Number: K943495 · 1994-09-08

ApplicantCoast Medical, Inc.
Decision Date1994-09-08
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ESOPHAGEAL STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Coast Medical, Inc.. It received FDA 510(k) clearance on 1994-09-08 under 510(k) number K943495. 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 DISPOSABLE ESOPHAGEAL STETHOSCOPE?

DISPOSABLE ESOPHAGEAL STETHOSCOPE is a medical device that received FDA 510(k) clearance on 1994-09-08. The listed applicant is Coast Medical, Inc.. The 510(k) number is K943495.

When did DISPOSABLE ESOPHAGEAL STETHOSCOPE receive FDA 510(k) clearance?

DISPOSABLE ESOPHAGEAL STETHOSCOPE received FDA 510(k) clearance on 1994-09-08, under 510(k) number K943495.

Who is the listed applicant for DISPOSABLE ESOPHAGEAL STETHOSCOPE?

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

What is the FDA product code for DISPOSABLE ESOPHAGEAL STETHOSCOPE?

The FDA product code for DISPOSABLE ESOPHAGEAL STETHOSCOPE 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 Coast 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.

K952243EXTENSION SET/I.V. SETK944729STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCEK943270SURFACE TEMPERATURE PROBESK943110GAS SAMPLING INTERFACES

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.

↑