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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 K930533
Device Name BNOS MICROVENT(TM), MODEL AC AND MODEL AO
Applicant
BNOS MEDITECH, LTD.
MILL LANE STEBBING
ESSEX,  GB CM6 3SL
Applicant Contact HOWARD BUCKENLHAM
Correspondent
BNOS MEDITECH, LTD.
MILL LANE STEBBING
ESSEX,  GB CM6 3SL
Correspondent Contact HOWARD BUCKENLHAM
Regulation Number868.1920
Classification Product Code
BZT  
Date Received02/02/1993
Decision Date 03/29/1993
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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