The following data is part of a premarket notification filed by Navifus Corporation with the FDA for Navirfa Scope.
| Device ID | K211529 |
| 510k Number | K211529 |
| Device Name: | NAVIRFA Scope |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | NaviFUS Corporation 12F., No. 246, Sec. 3, Chengde Rd. Datong Dist., Taipei City, TW 10367 |
| Contact | Arthur Lung |
| Correspondent | Arthur Lung NaviFUS Corporation 12F., No. 246, Sec. 3, Chengde Rd. Datong Dist., Taipei City, TW 10367 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-17 |
| Decision Date | 2022-05-05 |