• 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 K191828
Device Name Vathin Video Bronchoscope System
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Building 12, No 9 Chuanqi west road,
Jiuhua Economic Development Zone
Xiangtan,  CN 411100
Applicant Contact Yun Feng
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9th Floor, R&D Building, N0., 26 Qinglan Street,
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Mike Gu
Regulation Number874.4680
Classification Product Code
Date Received07/08/2019
Decision Date 02/13/2020
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