The following data is part of a premarket notification filed by Witt Biomedical Corp with the FDA for Xper Information Management/physiomonitoring 5 System And/or Vascular 5, Patient Care Console And Central Station.
| Device ID | K063840 |
| 510k Number | K063840 |
| Device Name: | XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | WITT BIOMEDICAL CORP 305 NORTH DR. Melbourne, FL 32934 |
| Contact | James Luker |
| Correspondent | James Luker WITT BIOMEDICAL CORP 305 NORTH DR. Melbourne, FL 32934 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-26 |
| Decision Date | 2007-02-06 |
| Summary: | summary |