The following data is part of a premarket notification filed by Heine Optotechnik Gmbh & Co. Kg. with the FDA for Heine Mini 3000 Led Ophthalmoscope.
| Device ID | K123587 |
| 510k Number | K123587 |
| Device Name: | HEINE MINI 3000 LED OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | HEINE OPTOTECHNIK GMBH & CO. KG. KIENTALSTRASSE 7 Herrsching, DE D-82211 |
| Contact | Joerg Roennau |
| Correspondent | Olaf Teichert TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-03-22 |
| Summary: | summary |