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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K910452
Device Name RESPI-PAK RT-PAK
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 Number868.1840
Classification Product Code
BZG  
Date Received02/01/1991
Decision Date 04/16/1991
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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