The following data is part of a premarket notification filed by Philips Medical Systems Nederlands B.v. with the FDA for Clarifeye R1.0, Clarifeye Needle.
| Device ID | K201743 |
| 510k Number | K201743 |
| Device Name: | ClarifEye R1.0, ClarifEye Needle |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Philips Medical Systems Nederlands B.V. Veenpluis 6 Best, NL 5684pc |
| Contact | Owen Callaghan |
| Correspondent | Owen Callaghan Philips Medical Systems Nederlands B.V. Veenpluis 6 Best, NL 5684pc |
| Product Code | OWB |
| Subsequent Product Code | HAW |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-25 |
| Decision Date | 2021-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838104570 | K201743 | 000 |
| 00884838097575 | K201743 | 000 |