K162012 is an FDA 510(k) clearance for the CARESCAPE Central Station V2. This device is classified as a Display, Cathode-ray Tube, Medical (Class II - Special Controls, product code DXJ).
Submitted by Ge Healthcare (Milwaukee, US). The FDA issued a Cleared decision on September 15, 2016, 56 days after receiving the submission on July 21, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2450.
| 510(k) Number | K162012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2016 |
| Decision Date | September 15, 2016 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXJ — Display, Cathode-ray Tube, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2450 |