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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stethoscope, esophageal, with electrical conductors
510(k) Number K862672
Device Name ESOPHAGEAL STETHOSCOPE WITH THERMISTOR
Applicant
INMED CORP.
3030-B HOLCOMB BRIDGE RD.
NORCROSS,  GA  30071
Applicant Contact BLACKWOOD HYAMS
Correspondent
INMED CORP.
3030-B HOLCOMB BRIDGE RD.
NORCROSS,  GA  30071
Correspondent Contact BLACKWOOD HYAMS
Regulation Number868.1920
Classification Product Code
BZT  
Date Received07/14/1986
Decision Date 10/27/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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