HEINE OMEGA 500
Ophthalmoscope, Ac-powered
HEINE OPTOTECHNIK GMBH & CO. KG.
The following data is part of a premarket notification filed by Heine Optotechnik Gmbh & Co. Kg. with the FDA for Heine Omega 500.
Pre-market Notification Details
| Device ID | K123316 |
| 510k Number | K123316 |
| Device Name: | HEINE OMEGA 500 |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | HEINE OPTOTECHNIK GMBH & CO. KG. KIENTALSTRASSE 7 Herrsching, DE D-82211 |
| Contact | Jorg Ronnau |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-10-25 |
| Decision Date | 2013-02-26 |
| Summary: | summary |
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