The following data is part of a premarket notification filed by Heine Optotechnik Gmbh & Co. Kg with the FDA for Heine Beta 200, Heine Beta 200 S, Heine K 180.
| Device ID | K142486 |
| 510k Number | K142486 |
| Device Name: | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | HEINE Optotechnik GmbH & Co. KG Kientalstr. 7 Herrsching, DE 82211 |
| Contact | Bettina Seim |
| Correspondent | Belinda Labourdette HEINE USA Ltd. 10 Innovation Way Dover, NH 03820 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-04 |
| Decision Date | 2015-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00192896088566 | K142486 | 000 |
| B099X007993810 | K142486 | 000 |
| B099X007996500 | K142486 | 000 |
| B099X007996610 | K142486 | 000 |
| B099X007996650 | K142486 | 000 |
| B099X007996660 | K142486 | 000 |
| B099X000996670 | K142486 | 000 |
| B099X007996710 | K142486 | 000 |
| B099X007996720 | K142486 | 000 |
| B099X007996760 | K142486 | 000 |
| 00192896009608 | K142486 | 000 |
| 00192896009615 | K142486 | 000 |
| 00192896009622 | K142486 | 000 |
| 00192896088559 | K142486 | 000 |
| B099X007993760 | K142486 | 000 |