The following data is part of a premarket notification filed by Rossmax International Ltd. with the FDA for Rossmax Medipro Model 10 And 60, Medicare Model 10 And 60 Blood Pressure Monitors.
| Device ID | K013583 |
| 510k Number | K013583 |
| Device Name: | ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ROSSMAX INTERNATIONAL LTD. 12F., NO.189, KANG CHIEN RD. Taipei, TW 114 |
| Contact | Michael Yeh |
| Correspondent | Michael Yeh ROSSMAX INTERNATIONAL LTD. 12F., NO.189, KANG CHIEN RD. Taipei, TW 114 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-30 |
| Decision Date | 2002-01-17 |