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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
Predetermined Change
Control Plan Authorized		 No
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