The following data is part of a premarket notification filed by Suntech Medical, Inc. with the FDA for 247 Bp Device.
| Device ID | K070750 |
| 510k Number | K070750 |
| Device Name: | 247 BP DEVICE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 117 Morrisville, NC 27560 |
| Contact | Chuck Setzer |
| Correspondent | Chuck Setzer SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 117 Morrisville, NC 27560 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-19 |
| Decision Date | 2007-05-02 |
| Summary: | summary |