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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, cardiac (incl. cardiotachometer & rate alarm)
510(k) Number K223163
Device Name Sleepiz One+
Applicant
Sleepiz AG
Hornbachstrasse 23
Zurich,  CH 8008
Applicant Contact Marta Stepien
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.2300
Classification Product Code
DRT  
Subsequent Product Code
BZQ  
Date Received10/07/2022
Decision Date 08/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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