The following data is part of a premarket notification filed by Odin Medical Technologies Ltd. with the FDA for Flexicoil - Malleable Receive-only Surface Coil.
| Device ID | K020601 |
| 510k Number | K020601 |
| Device Name: | FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | ODIN MEDICAL TECHNOLOGIES LTD. P.O. BOX 248 Yokneam Elit, IL 20692 |
| Contact | Adi Ickowicz |
| Correspondent | Adi Ickowicz ODIN MEDICAL TECHNOLOGIES LTD. P.O. BOX 248 Yokneam Elit, IL 20692 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-22 |
| Decision Date | 2002-04-24 |
| Summary: | summary |