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 insufflator, automatic carbon-dioxide for endoscope
510(k) Number K190985
Device Name BAROnova Insufflation System, BAROnova Accessory Kit
Applicant
BAROnova, Inc.
1551 Industrial Road
San Carlos,  CA  94070
Applicant Contact Lian Cunningham
Correspondent
BAROnova, Inc.
1551 Industrial Road
San Carlos,  CA  94070
Correspondent Contact Lian Cunningham
Regulation Number876.1500
Classification Product Code
FCX  
Subsequent Product Code
FEQ  
Date Received04/15/2019
Decision Date 05/14/2019
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-