The following data is part of a premarket notification filed by Canon Components, Inc. with the FDA for Digital Retinal Camera Cx-1.
| Device ID | K092565 |
| 510k Number | K092565 |
| Device Name: | DIGITAL RETINAL CAMERA CX-1 |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CANON COMPONENTS, INC. ONE CANON PLAZA Lake Success, NY 11042 |
| Contact | Sheila Driscoll |
| Correspondent | Jeff Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-08-20 |
| Decision Date | 2010-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04549292074345 | K092565 | 000 |