• 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 transducer, tremor
510(k) Number K213519
Device Name Rune Labs Tremor Transducer System
Rune Labs, Inc.
649 Iriving Street
San Francisco,  CA  94122
Applicant Contact Brian Pepin
Anacapa Clinical Research Inc.
2421 Sunset Dr.
Ventura,  CA  93001
Correspondent Contact Courtney Lane
Regulation Number882.1950
Classification Product Code
Subsequent Product Codes
Date Received11/03/2021
Decision Date 06/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No