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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 K203231
Device Name Switched Internal Paddles
Applicant
Philips North America, LLC
22100 Bothell Everett Hwy.
Bothell,  WA  98021
Applicant Contact Neha Hardiya
Correspondent
Philips North America, LLC
22100 Bothell Everett Hwy.
Bothell,  WA  98021
Correspondent Contact Neha Hardiya
Regulation Number870.5300
Classification Product Code
LDD  
Date Received11/02/2020
Decision Date 01/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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