The following data is part of a premarket notification filed by Witt Biomedical Corp with the FDA for Calysto Series Iv Patient Care Monitors And Central Station And Ecg Management System.
| Device ID | K033030 |
| 510k Number | K033030 |
| Device Name: | CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | WITT BIOMEDICAL CORP 305 NORTH DR. Melbourne, FL 32934 |
| Contact | Elfriede Pagan |
| Correspondent | Elfriede Pagan 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 | 2003-09-26 |
| Decision Date | 2004-02-24 |