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 K191272
Device Name Wearable Device, Wearable Package
Applicant
Current Health , Ltd.
Playfair House, 12a Broughton St. Lane
Edinburgh,  GB EH1 3LY
Applicant Contact Edwin Lindsay
Correspondent
Current Health , Ltd.
Playfair House, 12a Broughton St. Lane
Edinburgh,  GB EH1 3LY
Correspondent Contact Edwin Lindsay
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
BZG   BZQ   DQA   DRG   FLL  
Date Received05/13/2019
Decision Date 07/12/2019
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
-
-