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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K884910
Device Name MODEL 1010, CY-MET
Applicant
Cybermedic, Inc.
740 So Pierce Ave.
P.O. Box 700
Louisville,  CO  80027
Applicant Contact LEWIS WARD
Correspondent
Cybermedic, Inc.
740 So Pierce Ave.
P.O. Box 700
Louisville,  CO  80027
Correspondent Contact LEWIS WARD
Regulation Number868.1850
Classification Product Code
BZK  
Date Received11/25/1988
Decision Date 06/12/1989
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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