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 System, Nuclear Magnetic Resonance Imaging
510(k) Number K010057
Device Name MODIFICATION TO ARTOSCAN M
Applicant
BIOSOUND ESAOTE, INC.
8000 CASTLEWAY DR.
INDIANAPOLIS,  IN  46250
Applicant Contact COLLEEN HITTLE
Correspondent
BIOSOUND ESAOTE, INC.
8000 CASTLEWAY DR.
INDIANAPOLIS,  IN  46250
Correspondent Contact COLLEEN HITTLE
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/08/2001
Decision Date 02/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
-
-