• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K121243
Models MD-1000A, MD-1000A/P, MD-1000P
Device Name ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER
Original Applicant
MEDA CO. LTD.
13505 broadfield dr.
potomac,  MD  20854
Original Contact kai chen
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received04/25/2012
Decision Date 05/03/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-