The following data is part of a premarket notification filed by Witt Biomedical Corporation with the FDA for Witt Biomedical Series Ii-ep.
| Device ID | K923054 |
| 510k Number | K923054 |
| Device Name: | WITT BIOMEDICAL SERIES II-EP |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | WITT BIOMEDICAL CORPORATION 295 NORTH DR. SUITE H Melbourne, FL 32934 |
| Contact | Terence R Witt |
| Correspondent | Terence R Witt 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 | 1992-06-24 |
| Decision Date | 1993-02-25 |