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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 K820746
Device Name NEWPORT VENTILATOR MODEL E100
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
NEWPORT MEDICAL INSTRUMENTS, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/19/1982
Decision Date 04/16/1982
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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