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 stimulator, spinal-cord, implanted (pain relief)
510(k) Number K183047
Device Name Nalu Neurostimulation System
Applicant
Nalu Medical, Inc
1525 Faraday Ave. Suite 180
Carlsbad,  CA  92008
Applicant Contact Michele Chin-Purcell
Correspondent
Nalu Medical, Inc
1525 Faraday Ave. Suite 180
Carlsbad,  CA  92008
Correspondent Contact Michele Chin-Purcell
Regulation Number882.5880
Classification Product Code
GZB  
Date Received11/02/2018
Decision Date 03/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-