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 Computer, Diagnostic, Programmable
510(k) Number K220786
Device Name STAR Apollo Mapping System
Applicant
Rhythm Al, Ltd
Office G2, Whitney Business and Innovation, Windrush House,
Buford Rd
Witney,  GB OX 29 7DX
Applicant Contact Linda D'Abate
Correspondent
Rhythm-Al
124 Gilbert Stuart Drive
East Greenwich,  RI  02818
Correspondent Contact Linda D'Abate
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/17/2022
Decision Date 12/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-