Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K220810
Infinity OCT System and PASS OCT Spinal System · Medicrea International · decided 2022-04-19 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Medicrea UNiD OCT | B33243599-01 | MEDICREA INTERNATIONAL | NKG | 03613720289999 |
| Medicrea UNiD OCT | B33223599-01 | MEDICREA INTERNATIONAL | NKG | 03613720289937 |
| Medicrea UNiD OCT | B33123599-01 | MEDICREA INTERNATIONAL | NKG | 03613720289838 |
| Medicrea UNiD OCT | B33143499-01 | MEDICREA INTERNATIONAL | NKG | 03613720289876 |
| Medicrea UNiD OCT | B33123599-02 | MEDICREA INTERNATIONAL | NKG | 03613720289852 |
| Medicrea UNiD OCT | B33223599-02 | MEDICREA INTERNATIONAL | NKG | 03613720289951 |
| Medicrea UNiD OCT | B33243499-01 | MEDICREA INTERNATIONAL | NKG | 03613720289975 |
| Medicrea UNiD OCT | B33143400-01 | MEDICREA INTERNATIONAL | NKG | 03613720287650 |
| Medicrea UNiD OCT | B33243400-01 | MEDICREA INTERNATIONAL | NKG | 03613720287674 |
| Medicrea UNiD OCT | B33143599-01 | MEDICREA INTERNATIONAL | NKG | 03613720289890 |
| Medicrea UNiD OCT | B33243699-01 | MEDICREA INTERNATIONAL | NKG | 03613720290018 |
| Medicrea UNiD OCT | B33143699-01 | MEDICREA INTERNATIONAL | NKG | 03613720289913 |