The following data is part of a premarket notification filed by Sedecal Sa with the FDA for Phoenix/aerodr Tx M01 And Phoenix/mkdr Xpress..
| Device ID | K221803 |
| 510k Number | K221803 |
| Device Name: | PHOENIX/AeroDR TX M01 And PHOENIX/mKDR Xpress. |
| Classification | System, X-ray, Mobile |
| Applicant | SEDECAL SA C/ Pelaya, 9 – 13 Pol. Ind. Río De Janeiro Algete, ES 28110 |
| Contact | Ma Luisa Gomez De Aguero |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-22 |
| Decision Date | 2022-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08436046003170 | K221803 | 000 |
| 08436046003163 | K221803 | 000 |
| 08436046003156 | K221803 | 000 |
| 08436046003149 | K221803 | 000 |
| 08436046003132 | K221803 | 000 |
| 08436046003125 | K221803 | 000 |
| 08436046003118 | K221803 | 000 |
| 08436046003101 | K221803 | 000 |