The following data is part of a premarket notification filed by Heine Optotechnik Gmbh & Co. Kg with the FDA for Heine Sigma 250 & Heine Sigma 250 M2.
| Device ID | K142837 |
| 510k Number | K142837 |
| Device Name: | HEINE SIGMA 250 & HEINE SIGMA 250 M2 |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | HEINE Optotechnik GmbH & Co. KG Kientalstr. 7 Herrsching, DE 82211 |
| Contact | Bettina Seim |
| Correspondent | Bettina Seim HEINE Optotechnik GmbH & Co. KG Kientalstr. 7 Herrsching, DE 82211 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-01-29 |
| Summary: | summary |