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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Paper Chart
510(k) Number K870119
Device Name FIBRE OPTIC STRIP CHART RECORDER
Applicant
Apex Imaging Corp.
1836 Evergreen
Duarte,  CA  91010
Applicant Contact HAROLD ROSENBERG
Correspondent
Apex Imaging Corp.
1836 Evergreen
Duarte,  CA  91010
Correspondent Contact HAROLD ROSENBERG
Regulation Number870.2810
Classification Product Code
DSF  
Date Received01/12/1987
Decision Date 04/10/1987
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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