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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Electrode, Surface, Electrocardiographic
510(k) Number K830823
Device Name Z VIEW METER MODEL 300
Applicant
Lintronics Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Lintronics Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2370
Classification Product Code
KRC  
Date Received03/15/1983
Decision Date 05/18/1983
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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