YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP

Stethoscope, Esophageal, With Electrical Conductors

YELLOW SPRINGS INSTRUMENT CO., INC.

The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Ysi Models 4400 & 4700 Esophageal Stethoscope Temp.

Pre-market Notification Details

Device IDK893409
510k NumberK893409
Device Name:YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
ClassificationStethoscope, Esophageal, With Electrical Conductors
Applicant YELLOW SPRINGS INSTRUMENT CO., INC. 1725 BRANNUM LN. Yellow Springs,  OH  45387
ContactFred Breidt
CorrespondentFred Breidt
YELLOW SPRINGS INSTRUMENT CO., INC. 1725 BRANNUM LN. Yellow Springs,  OH  45387
Product CodeBZT  
CFR Regulation Number868.1920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-10
Decision Date1989-07-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884838006908 K893409 000
20884838006892 K893409 000
20884838006885 K893409 000

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