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 Device, Positive Pressure Breathing, Intermittent
510(k) Number K231728
Device Name BiWaze Clear System
Applicant
Abmrc, LLC
860 Blue Gentian Rd., Suite 200
Eagan,  MN  55121
Applicant Contact Leah Noaeill
Correspondent
Abmrc, LLC
860 Blue Gentian Rd., Suite 200
Eagan,  MN  55121
Correspondent Contact Priyanka Paul
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received06/13/2023
Decision Date 04/08/2024
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
-
-