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 Device, Sleep Assessment
510(k) Number K233987
Device Name VERABAND™
Applicant
Arbor Medical Innovations, LLC
168 S. Industrial Dr.
Saline,  MI  48176
Applicant Contact Grant Kruger
Correspondent
Medical Device Regulatory Solutions, LLC
230 Collingwood Dr., Suite 260
Ann Arbor,  MI  48103
Correspondent Contact Kay Fuller
Regulation Number882.5050
Classification Product Code
LEL  
Subsequent Product Code
ISD  
Date Received12/18/2023
Decision Date 06/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-