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 Non-Invasive Vagus Nerve Stimulator - Headache
510(k) Number K191830
Device Name gammaCore Sapphire
Applicant
Electrocore, Inc.
150 Allen Rd., Suite 201
Basking Ridge,  NJ  07920
Applicant Contact Mike Romaniw
Correspondent
Electrocore, Inc.
150 Allen Rd., Suite 201
Basking Ridge,  NJ  07920
Correspondent Contact Mike Romaniw
Regulation Number882.5892
Classification Product Code
PKR  
Subsequent Product Code
QAK  
Date Received07/09/2019
Decision Date 03/26/2020
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
-
-