The following data is part of a premarket notification filed by Witt Biomedical Corporation with the FDA for Witt Biomedical Central Station Monitoring System And Witt Biomedical Advanced Patient Care Monitoring Units.
| Device ID | K973474 |
| 510k Number | K973474 |
| Device Name: | WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | WITT BIOMEDICAL CORPORATION 295 NORTH DR., SUITE H Melbourne, FL 32934 |
| Contact | Lorraine R Fredes |
| Correspondent | Lorraine R Fredes WITT BIOMEDICAL CORPORATION 295 NORTH DR., SUITE H Melbourne, FL 32934 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-12 |
| Decision Date | 1998-03-13 |