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 Reprocessed Bronchoscope
510(k) Number K231473
Device Name Monarch Bronchoscope
Applicant
Auris Health, Inc., A Johnson and Johnson Family Company
150 Shoreline Dr.
Redwood,  CA  94065
Applicant Contact Somi Ekwealor
Correspondent
Auris Health, Inc., A Johnson and Johnson Family Company
150 Shoreline Dr.
Redwood,  CA  94065
Correspondent Contact Patrick Garvey
Regulation Number874.4680
Classification Product Code
QNW  
Date Received05/22/2023
Decision Date 11/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-