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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K861240
Device Name BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER
Applicant
Mountain View Medical
1499 Pomona Rd., Suite F
Corona,  CA  91720
Applicant Contact JAMES C BECHLER
Correspondent
Mountain View Medical
1499 Pomona Rd., Suite F
Corona,  CA  91720
Correspondent Contact JAMES C BECHLER
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/02/1986
Decision Date 05/02/1986
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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