The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Carescape Central Station V2.
| Device ID | K162012 |
| 510k Number | K162012 |
| Device Name: | CARESCAPE Central Station V2 |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | GE HEALTHCARE 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Robert Casarsa |
| Correspondent | Robert Casarsa GE HEALTHCARE 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DXJ |
| Subsequent Product Code | DQK |
| Subsequent Product Code | DSI |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-21 |
| Decision Date | 2016-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682109666 | K162012 | 000 |
| 00840682109604 | K162012 | 000 |