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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, monitoring (w/wo alarm)
510(k) Number K890724
Device Name MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
Applicant
BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Applicant Contact KAORU LEE
Correspondent
BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Correspondent Contact KAORU LEE
Regulation Number868.1850
Classification Product Code
BZK  
Date Received02/13/1989
Decision Date 03/30/1989
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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