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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aid, Cardiopulmonary Resuscitation
510(k) Number K843977
Device Name PULSE-AID DEVICE
Applicant
James J. Lally
4620 J.C. Nichols Pkwy.
Plz. Pkwy. Bldg.
Kansas City,  MO  64112
Applicant Contact JAMES J LALLY
Correspondent
James J. Lally
4620 J.C. Nichols Pkwy.
Plz. Pkwy. Bldg.
Kansas City,  MO  64112
Correspondent Contact JAMES J LALLY
Regulation Number870.5210
Classification Product Code
LIX  
Date Received10/05/1984
Decision Date 02/01/1985
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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