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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K851485
Device Name DEFI 502
Applicant
Robert Bosch Corp.
Flower Field Bldg. #17
Mill Pond Rd.
St. James,  NY  11780
Applicant Contact ANDREW SCHAEFFER
Correspondent
Robert Bosch Corp.
Flower Field Bldg. #17
Mill Pond Rd.
St. James,  NY  11780
Correspondent Contact ANDREW SCHAEFFER
Regulation Number870.5300
Classification Product Code
LDD  
Date Received04/15/1985
Decision Date 08/29/1985
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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