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 camera, ophthalmic, ac-powered
510(k) Number K952480
Device Name ORIMS DIGITAL ANGIOGRAPHY SYSTEM
Applicant
MIDWEST OPHTHALMIC INSTRUMENTS, INC.
1237 NAPERVILLE DR.
ROMEOVILLE,  IL  60441
Applicant Contact JAMES J URBAN
Correspondent
MIDWEST OPHTHALMIC INSTRUMENTS, INC.
1237 NAPERVILLE DR.
ROMEOVILLE,  IL  60441
Correspondent Contact JAMES J URBAN
Regulation Number886.1120
Classification Product Code
HKI  
Date Received05/30/1995
Decision Date 08/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-