ESOPHAGEAL STETH. TEMP. SENSOR

Stethoscope, Esophageal

LABARGE, INC.

The following data is part of a premarket notification filed by Labarge, Inc. with the FDA for Esophageal Steth. Temp. Sensor.

Pre-market Notification Details

Device IDK771411
510k NumberK771411
Device Name:ESOPHAGEAL STETH. TEMP. SENSOR
ClassificationStethoscope, Esophageal
Applicant LABARGE, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeBZW  
CFR Regulation Number868.1910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-08-01
Decision Date1977-09-23

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