The following data is part of a premarket notification filed by Crystalvue Medical Corporation with the FDA for Nfc-600 Automated Portable Retinal Camera.
| Device ID | K210197 |
| 510k Number | K210197 |
| Device Name: | NFC-600 Automated Portable Retinal Camera |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Crystalvue Medical Corporation No.116, Ln.956, Zhongshan Rd., Taoyuan Dist., Taoyuan, TW 33072 |
| Contact | Oliver Lin |
| Correspondent | Oliver Lin Crystalvue Medical Corporation No.116, Ln.956, Zhongshan Rd., Taoyuan Dist., Taoyuan, TW 33072 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-25 |
| Decision Date | 2021-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719876420275 | K210197 | 000 |
| 04719876420268 | K210197 | 000 |