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 Ophthalmoscope, Battery-Powered
510(k) Number K871735
Device Name VOROSCOPE(TM)
Applicant
Australian Biomedical Corporation , Ltd.
39 Dehavilland Rd.
Mordialloc, Vic. 3195
Australia,  AU
Applicant Contact DAVID WHITEHEAD
Correspondent
Australian Biomedical Corporation , Ltd.
39 Dehavilland Rd.
Mordialloc, Vic. 3195
Australia,  AU
Correspondent Contact DAVID WHITEHEAD
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received05/05/1987
Decision Date 06/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-