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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, breathing frequency
510(k) Number K880725
Device Name SAM(TM) MODEL ONE
Applicant
SENTEL TECH. C/O CRITICARE SYSTEMS, INC.
10054 PROSPECT AVE.
SUITE B
SANTEE,  CA  92071
Applicant Contact LAI, PH.D.
Correspondent
SENTEL TECH. C/O CRITICARE SYSTEMS, INC.
10054 PROSPECT AVE.
SUITE B
SANTEE,  CA  92071
Correspondent Contact LAI, PH.D.
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received02/23/1988
Decision Date 09/06/1988
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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