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 Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K121132
Device Name EZSENSOR P DIGITAL INTRAORAL SENSOR
Applicant
Humanray Co,Ltd
12946 Kimberley Ln.
Houston,  TX  77079
Applicant Contact DAVE KIM
Correspondent
Humanray Co,Ltd
12946 Kimberley Ln.
Houston,  TX  77079
Correspondent Contact DAVE KIM
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/13/2012
Decision Date 05/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-