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 Coil, Magnetic Resonance, Specialty
510(k) Number K984257
Device Name MEDRAD PHASED ARRAY NEUROVASCULAR COIL
Applicant
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Applicant Contact JIM FERGUSON, JR.
Correspondent
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Correspondent Contact JIM FERGUSON, JR.
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/30/1998
Decision Date 01/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-