The following data is part of a premarket notification filed by Neocoil, Llc with the FDA for 3.0t Metaflexcoil.
| Device ID | K103342 |
| 510k Number | K103342 |
| Device Name: | 3.0T METAFLEXCOIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NEOCOIL, LLC N27 W23910A PAUL RD. Pewaukee, WI 53072 |
| Contact | Brian Brown |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-11-15 |
| Decision Date | 2010-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856181003145 | K103342 | 000 |
| 00856181003138 | K103342 | 000 |
| 00856181003121 | K103342 | 000 |
| 00856181003114 | K103342 | 000 |