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 transducer, ultrasonic, diagnostic
510(k) Number K070195
Device Name BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B
Applicant
BROADSOUND CORPORATION
5F, NO.31 SHINTAI ROAD
JUIPEI CITY, HSINCHU,  TW 30252
Applicant Contact JIANN HWA JENG, PHD
Correspondent
BROADSOUND CORPORATION
5F, NO.31 SHINTAI ROAD
JUIPEI CITY, HSINCHU,  TW 30252
Correspondent Contact JIANN HWA JENG, PHD
Regulation Number892.1570
Classification Product Code
ITX  
Date Received01/22/2007
Decision Date 10/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-