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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K232111
Device Name NeoBeat, NeoBeat Mini
Applicant
Laerdal Medical AS
Tanke Svilandsgate 30
P.O. Box 377
Stavanger,  NO 4002
Applicant Contact Mari Kaada
Correspondent
MED Institute
1330 Win Hentschel Blvd
West Lafayette,  IN  47906
Correspondent Contact Daniel J. Dillon, M.S., RAC
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/14/2023
Decision Date 06/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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