• 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 System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K171309
Device Name BR-FHUS Navigation 1.0
Applicant
TaiHao Medical Inc.
3F.-8, No.100, Sec. 2
Heping E. Rd., Da'am Dist.
Taipei,  TW 10663
Applicant Contact Hsin Hung Lai
Correspondent
Lin & Associates, LLC
5614 Johnson Avenue
Bethesda,  MD  20817
Correspondent Contact Chiu S. Lin
Regulation Number892.1560
Classification Product Code
IYO  
Date Received05/03/2017
Decision Date 09/29/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-