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 Ventilator, Non-Continuous (Respirator)
510(k) Number K242547
Device Name AirFit F20 Mask System; AirFit F20 NM Mask System
Applicant
Resmed Pty , Ltd.
1 Elizabeth Macarthur Dr.
Bella Vista,  AU 2153
Applicant Contact Lawrence Colin Kwan
Correspondent
ResMed Corp
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Correspondent Contact Jason Gorman
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/27/2024
Decision Date 05/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-