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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K820885
Device Name MARQUETTE OPTION II ECG ANALYSIS COMPUT
Applicant
Marquette Electronics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Marquette Electronics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LOS
Date Received03/30/1982
Decision Date 04/15/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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