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 System, Network And Communication, Physiological Monitors
510(k) Number K261367
Device Name Corsano CardioWatch 287-2 System
Applicant
Corsano Health B.V.
Waldorpstraat 5
The Hague,  NL 2521
Applicant Contact Peter STAS
Correspondent
Corsano Health B.V.
Waldorpstraat 5
The Hague,  NL 2521
Correspondent Contact Peter STAS
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
BZG   BZQ   DQA   DRG   DXN  
FLL   FRI   LEL  
Date Received04/27/2026
Decision Date 07/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-