The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Active Ecg Electrodes Magnetom Vision Systems.
| Device ID | K983327 |
| 510k Number | K983327 |
| Device Name: | ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Durkhani Roshan |
| Correspondent | Durkhani Roshan SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-22 |
| Decision Date | 1998-10-09 |
| Summary: | summary |