LIFESOUND ESOPHAGEAL STETHOSCOPE

Stethoscope, Esophageal, With Electrical Conductors

BIOMEDICAL CONCEPTS, INC.

The following data is part of a premarket notification filed by Biomedical Concepts, Inc. with the FDA for Lifesound Esophageal Stethoscope.

Pre-market Notification Details

Device IDK811928
510k NumberK811928
Device Name:LIFESOUND ESOPHAGEAL STETHOSCOPE
ClassificationStethoscope, Esophageal, With Electrical Conductors
Applicant BIOMEDICAL CONCEPTS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeBZT  
CFR Regulation Number868.1920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-06
Decision Date1981-07-28

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