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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K852900
Device Name CVERNE CAD DETECTOR
Applicant
Cherne Industries, Inc.
5701 S. County Rd. 18
Minneapolis,  MN  55436
Applicant Contact MARK W KROLL
Correspondent
Cherne Industries, Inc.
5701 S. County Rd. 18
Minneapolis,  MN  55436
Correspondent Contact MARK W KROLL
Regulation Number870.1435
Classification Product Code
DXG  
Date Received07/09/1985
Decision Date 09/25/1985
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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