The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Cdt Cal, Dimension Vista Cdt Con L, Dimension Vista Cdt Con H.
| Device ID | K110169 |
| 510k Number | K110169 |
| Device Name: | DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H |
| Classification | Calibrator, Secondary |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Contact | Kathleen Ann Dray-lyons |
| Correspondent | Kathleen Ann Dray-lyons SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-20 |
| Decision Date | 2011-04-07 |
| Summary: | summary |