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 |