Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K253388
Device Name Sleepiz One+ (Model 2.5)
Applicant
Sleepiz AG
Hornbachstrasse 23
Zurich,  CH 8008
Applicant Contact Marta Stepien
Correspondent
Sleepiz AG
Hornbachstrasse 23
Zurich,  CH 8008
Correspondent Contact Marta Stepien
Regulation Number870.2300
Classification Product Code
DRT  
Subsequent Product Code
BZQ  
Date Received09/30/2025
Decision Date 01/28/2026
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
-
-