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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 K992133
Device Name NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
760 WEST 16TH ST., BLDG. N
COSTA MESA,  CA  92627
Applicant Contact ROBERT W DICK
Correspondent
NEWPORT MEDICAL INSTRUMENTS, INC.
760 WEST 16TH ST., BLDG. N
COSTA MESA,  CA  92627
Correspondent Contact ROBERT W DICK
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/23/1999
Decision Date 08/04/2000
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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