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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory To Continuous Ventilator (Respirator)
510(k) Number K935788
Device Name BICORE SMARTCATH INTRATRACHEAL CATHETER
Applicant
Bicore Monitoring Systems
2-A Faraday
Irvine,  CA  92718
Applicant Contact MUIR S MEINHOLD
Correspondent
Bicore Monitoring Systems
2-A Faraday
Irvine,  CA  92718
Correspondent Contact MUIR S MEINHOLD
Regulation Number868.5895
Classification Product Code
MOD  
Date Received12/06/1993
Decision Date 07/03/1995
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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