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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 K905575
Device Name MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
Applicant
EDENTEC CORP.
10252 VALLEY VIEW RD.
EDEN PRAIRIE,  MN  55344
Applicant Contact Gary Syring
Correspondent
EDENTEC CORP.
10252 VALLEY VIEW RD.
EDEN PRAIRIE,  MN  55344
Correspondent Contact Gary Syring
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received12/12/1990
Decision Date 06/20/1991
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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