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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K942230
Device Name OXYCON-ALPHA
Applicant
Mijnhardt B.V.
Schoudermantel 37
3981 Ae Bunnik,  NL
Applicant Contact LEO DEN BAKKER
Correspondent
Mijnhardt B.V.
Schoudermantel 37
3981 Ae Bunnik,  NL
Correspondent Contact LEO DEN BAKKER
Regulation Number868.1890
Classification Product Code
BTY  
Date Received05/06/1994
Decision Date 03/20/1995
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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