The following data is part of a premarket notification filed by Rossmax International Ltd. with the FDA for Rossmax Automatic Wristwatch Blood Pressure Monitor, Model Rm-4000.
| Device ID | K964153 |
| 510k Number | K964153 |
| Device Name: | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ROSSMAX INTERNATIONAL LTD. 2F. NO. 10, ALLEY 20 LANE 106 SEC 3 NON KANG RD. Taipei, TW |
| Contact | Michael Yeh |
| Correspondent | Michael Yeh ROSSMAX INTERNATIONAL LTD. 2F. NO. 10, ALLEY 20 LANE 106 SEC 3 NON KANG RD. Taipei, TW |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-16 |
| Decision Date | 1998-06-11 |
| Summary: | summary |