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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K901060
Device Name EDENTEC MODEL 2000W SYSTEM 700 MONITOR
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 Number870.2700
Classification Product Code
DQA  
Date Received03/06/1990
Decision Date 05/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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