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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 K853346
Device Name BEAR NICU-1
Applicant
BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Applicant Contact RAY PIZINGER
Correspondent
BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Correspondent Contact RAY PIZINGER
Regulation Number868.1850
Classification Product Code
BZK  
Date Received08/12/1985
Decision Date 09/11/1985
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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