The following data is part of a premarket notification filed by Real Tone Technology Corp. with the FDA for Rtt Digital Wrist Blood Pressure Monitor, Model Rtw-8010a.
| Device ID | K060077 |
| 510k Number | K060077 |
| Device Name: | RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | REAL TONE TECHNOLOGY CORP. XI HUANG ROAD; XINZHUANG TOWN Shanghai, CN 201110 |
| Contact | Tom Wang |
| Correspondent | Tom Wang REAL TONE TECHNOLOGY CORP. XI HUANG ROAD; XINZHUANG TOWN Shanghai, CN 201110 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-10 |
| Decision Date | 2006-03-08 |