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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Gas Pressure
510(k) Number K897107
Device Name POLY G PHYSIOLOGICAL DATA RECORDER
Applicant
Cns, Inc.
7090 Shady Oak Rd.
Eden Prairie,  MN  55344
Applicant Contact JOHN F STOLTE
Correspondent
Cns, Inc.
7090 Shady Oak Rd.
Eden Prairie,  MN  55344
Correspondent Contact JOHN F STOLTE
Regulation Number868.2900
Classification Product Code
BXO  
Date Received12/21/1989
Decision Date 03/12/1990
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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