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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Cardiac, External
510(k) Number K221700
Device Name AutoPulse NXT Resuscitation System
Applicant
Zoll Circulation, Inc.
2000 Ringwood Ave.
San Jose,  CA  95131
Applicant Contact Brian Robey
Correspondent
Zoll Circulation, Inc.
2000 Ringwood Ave.
San Jose,  CA  95131
Correspondent Contact Brian Robey
Regulation Number870.5200
Classification Product Code
DRM  
Date Received06/13/2022
Decision Date 03/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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