• 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 ventilatory effort recorder
510(k) Number K231546
Device Name Somfit
Compumedics Limited
30-40 Flockhart St
Abbotsford,  AU 3067
Applicant Contact Michael Frischman
Compumedics Limited
30-40 Flockhart St
Abbotsford,  AU 3067
Correspondent Contact Michael Frischman
Regulation Number868.2375
Classification Product Code
Subsequent Product Code
Date Received05/30/2023
Decision Date 11/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No