The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Ophthalmoscope F-10.
| Device ID | K072259 |
| 510k Number | K072259 |
| Device Name: | OPHTHALMOSCOPE F-10 |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | NIDEK CO., LTD. 1733 CANTON LANE Marietta, GA 30062 |
| Contact | Paul Sumner |
| Correspondent | Paul Sumner NIDEK CO., LTD. 1733 CANTON LANE Marietta, GA 30062 |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-14 |
| Decision Date | 2008-05-06 |
| Summary: | summary |