The following data is part of a premarket notification filed by Mediana Co., Ltd. with the FDA for Lucon M-series Patient Monitor, Models M20 And M30.
| Device ID | K100217 |
| 510k Number | K100217 |
| Device Name: | LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-25 |
| Decision Date | 2010-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800003428929 | K100217 | 000 |
| 18800003427847 | K100217 | 000 |
| 18800003427205 | K100217 | 000 |