The following data is part of a premarket notification filed by Heine Optotechnik Gmbh & Co. Kg. with the FDA for Heine Beta 200(r) Ophthalmoscope.
| Device ID | K131961 |
| 510k Number | K131961 |
| Device Name: | HEINE BETA 200(R) OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | HEINE OPTOTECHNIK GMBH & CO. KG. KIENTALSTRASSE 7 Herrsching, DE D-82211 |
| Contact | Manfred Bartsch-tittmann |
| Correspondent | Manfred Bartsch-tittmann HEINE OPTOTECHNIK GMBH & CO. KG. KIENTALSTRASSE 7 Herrsching, DE D-82211 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2013-12-04 |
| Summary: | summary |