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 Electrocardiograph
510(k) Number K230812
Device Name Withings Scan Monitor 2.0
Applicant
Withings
2 rue Maurice Hartmann
Issy-Les-Moulineaux,  FR 92130
Applicant Contact Khushboo Surendran
Correspondent
Withings
2 rue Maurice Hartmann
Issy-Les-Moulineaux,  FR 92130
Correspondent Contact Khushboo Surendran
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
DXH  
Date Received03/24/2023
Decision Date 08/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT05266235
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-