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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 K883809
Device Name NEWPORT VENTILATOR MODEL E150
Applicant
Newport Medical Instruments, Inc.
760 W 16th St., Bldg. N
Costa Mesa,  CA  92627
Applicant Contact CYNDY MILLER
Correspondent
Newport Medical Instruments, Inc.
760 W 16th St., Bldg. N
Costa Mesa,  CA  92627
Correspondent Contact CYNDY MILLER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/08/1988
Decision Date 06/23/1989
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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