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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K853760
Device Name ADULT VENTILATOR TESTER VT-1
Applicant
BIO-TEK INSTRUMENTS, INC.
ONE MILL ST.
BURLINGTON,  VT  05401
Applicant Contact DAVID W KLYSZEIKO
Correspondent
BIO-TEK INSTRUMENTS, INC.
ONE MILL ST.
BURLINGTON,  VT  05401
Correspondent Contact DAVID W KLYSZEIKO
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/09/1985
Decision Date 12/03/1985
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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