The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for E-picco Continuous Cardiac Output Module And Accessories.
| Device ID | K132528 |
| 510k Number | K132528 |
| Device Name: | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2014-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104036 | K132528 | 000 |
| 00840682103039 | K132528 | 000 |
| 00840682103015 | K132528 | 000 |