The following data is part of a premarket notification filed by Suntech Medical, Inc. with the FDA for All Purpose Cuff, Model 222apc.
| Device ID | K051904 |
| 510k Number | K051904 |
| Device Name: | ALL PURPOSE CUFF, MODEL 222APC |
| Classification | Blood Pressure Cuff |
| Applicant | SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 117 Morrisville, NC 27560 |
| Contact | David Gallick |
| Correspondent | David Gallick SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 117 Morrisville, NC 27560 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-13 |
| Decision Date | 2005-09-09 |
| Summary: | summary |