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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 K834211
Device Name LEAP FROG
Applicant
Philips Medical Systems (Cleveland), Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Philips Medical Systems (Cleveland), Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1025
Classification Product Code
DSI  
Date Received12/05/1983
Decision Date 06/05/1984
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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