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 Bronchoscope (Flexible Or Rigid)
510(k) Number K202346
Device Name SPiN Vision Video Bronchoscope System
Applicant
Veran Medical Technologies, Inc.
1908 Innerbelt Business Center Dr.
St. Louis,  MO  63114
Applicant Contact B. Nathan Hunt
Correspondent
Veran Medical Technologies, Inc.
1908 Innerbelt Business Center Dr.
St. Louis,  MO  63114
Correspondent Contact B. Nathan Hunt
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received08/18/2020
Decision Date 02/19/2021
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
-
-