The following data is part of a premarket notification filed by Mediana Co., Ltd. with the FDA for Pulse Oximeter Model P10.
| Device ID | K100225 |
| 510k Number | K100225 |
| Device Name: | PULSE OXIMETER MODEL P10 |
| Classification | Oximeter |
| Applicant | MEDIANA CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack MEDIANA CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-26 |
| Decision Date | 2011-02-09 |
| Summary: | summary |