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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K861418
Device Name SPINNAKER
Applicant
Cybermedic, Inc.
P.O. Box 3468
Boulder,  CO  80307
Applicant Contact CURT BROWN
Correspondent
Cybermedic, Inc.
P.O. Box 3468
Boulder,  CO  80307
Correspondent Contact CURT BROWN
Regulation Number868.1880
Classification Product Code
BZC  
Date Received04/15/1986
Decision Date 05/09/1986
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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