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 K131961
Device Name HEINE BETA 200(R) OPHTHALMOSCOPE
Applicant
Heine Optotechnik GmbH & Co. KG
Kientalstrasse 7
Herrsching,  DE D-82211
Applicant Contact MANFRED BARTSCH-TITTMANN
Correspondent
Heine Optotechnik GmbH & Co. KG
Kientalstrasse 7
Herrsching,  DE D-82211
Correspondent Contact MANFRED BARTSCH-TITTMANN
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received06/27/2013
Decision Date 12/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-