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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Defibrillator
510(k) Number K182905
Device Name UniPulse
Applicant
Seaward Group
15-18 Bracken Hill
Peterlee,  GB SR8 2SW
Applicant Contact Jim Wallace
Correspondent
Steurer Consulting Group
800 Blue Quail Rd.
Keller,  TX  76248
Correspondent Contact Robert Steurer
Regulation Number870.5325
Classification Product Code
DRL  
Date Received10/16/2018
Decision Date 12/14/2018
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
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