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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 K844327
Device Name EDENTEC MODEL 2000W APNEA MONITOR
Applicant
EDENTEC CORP.
10252 VALLEY VIEW RD.
EDEN PRAIRIE,  MN  55344
Applicant Contact EDWARD SCHUCK
Correspondent
EDENTEC CORP.
10252 VALLEY VIEW RD.
EDEN PRAIRIE,  MN  55344
Correspondent Contact EDWARD SCHUCK
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received11/07/1984
Decision Date 07/15/1985
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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