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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K843538
Device Name PO 2 LYTRODE
Applicant
Polystan C/O Vitalcor, Inc.
Walgerholm 8
Ballerup Denmark, 
Applicant Contact HENNING S LARSEN
Correspondent
Polystan C/O Vitalcor, Inc.
Walgerholm 8
Ballerup Denmark, 
Correspondent Contact HENNING S LARSEN
Regulation Number870.4330
Classification Product Code
DRY  
Date Received09/07/1984
Decision Date 10/18/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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