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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 K904432
Device Name SLEEP I/T-5 AND SLEEP I/T-8
Applicant
Cns, Inc.
1250 Park Rd.
Chanhassen,  MN  55317
Applicant Contact JOHN STOLTE
Correspondent
Cns, Inc.
1250 Park Rd.
Chanhassen,  MN  55317
Correspondent Contact JOHN STOLTE
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received09/28/1990
Decision Date 07/10/1991
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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