The following data is part of a premarket notification filed by Witt Biomedical Corp with the FDA for Calysto Series Iv Physio-monitoring And Information System.
| Device ID | K063547 |
| 510k Number | K063547 |
| Device Name: | CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-24 |
| Decision Date | 2006-12-21 |
| Summary: | summary |