The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Vision Vxc Central Station, Model 4300.
| Device ID | K061675 |
| 510k Number | K061675 |
| Device Name: | VISION VXC CENTRAL STATION, MODEL 4300 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | INVIVO CORPORATION 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Contact | Maria Keelan |
| Correspondent | Maria Keelan INVIVO CORPORATION 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-14 |
| Decision Date | 2006-08-02 |
| Summary: | summary |