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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 K972833
Device Name E100M VENTILATOR (E100M)
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
760 WEST 16TH ST., BLDG. M
COSTA MESA,  CA  92627
Applicant Contact KARON MORELL
Correspondent
NEWPORT MEDICAL INSTRUMENTS, INC.
760 WEST 16TH ST., BLDG. M
COSTA MESA,  CA  92627
Correspondent Contact KARON MORELL
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/30/1997
Decision Date 09/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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