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, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K911584
Device Name DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480
Applicant
Pie Medical Equipment B.V.
Philipsweg 1
Maastricht,  NL 6227 AJ
Applicant Contact RIKERS
Correspondent
Pie Medical Equipment B.V.
Philipsweg 1
Maastricht,  NL 6227 AJ
Correspondent Contact RIKERS
Regulation Number892.1560
Classification Product Code
IYO  
Date Received04/08/1991
Decision Date 10/24/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-