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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 K921819
Device Name EDENTEC MODEL 3710 I DIGITAL PRINTER
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 Received04/15/1992
Decision Date 10/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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