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 K181077
Device Name ActiGraph CentrePoint Insight Watch
Applicant
Actigraph
49 E Chase St.
Pensacola,  FL  32502
Applicant Contact Brian Bell
Correspondent
Actigraph
49 E Chase St.
Pensacola,  FL  32502
Correspondent Contact Brian Bell
Regulation Number882.5050
Classification Product Code
LEL  
Date Received04/24/2018
Decision Date 05/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-