The following data is part of a premarket notification filed by Mediana Co., Ltd. with the FDA for Vital Signs Monitor.
| Device ID | K051375 |
| 510k Number | K051375 |
| Device Name: | VITAL SIGNS MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MEDIANA CO., LTD. 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack MEDIANA CO., LTD. 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-26 |
| Decision Date | 2005-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800003400574 | K051375 | 000 |
| 18800003400567 | K051375 | 000 |