The following data is part of a premarket notification filed by Suntech Medical Instruments, Inc. with the FDA for Tango Non-invasive Blood Pressure Monitor.
| Device ID | K970629 |
| 510k Number | K970629 |
| Device Name: | TANGO NON-INVASIVE BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SUNTECH MEDICAL INSTRUMENTS, INC. 8917 GLENWOOD AVE. Raleigh, NC 27617 |
| Contact | David Gallick |
| Correspondent | David Gallick SUNTECH MEDICAL INSTRUMENTS, INC. 8917 GLENWOOD AVE. Raleigh, NC 27617 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-19 |
| Decision Date | 1998-01-02 |