The following data is part of a premarket notification filed by Rossmax International Ltd. with the FDA for Rossmax Automatic Blood Pressure Monitor Model Mo701k.
| Device ID | K060342 |
| 510k Number | K060342 |
| Device Name: | ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ROSSMAX INTERNATIONAL LTD. 12F., NO.189, KANG CHIEN RD. Taipei, TW 114 |
| Contact | Mark Lin |
| Correspondent | Mark Lin 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 | 2006-02-10 |
| Decision Date | 2006-04-04 |