The following data is part of a premarket notification filed by Neocoil, Llc with the FDA for 1.5t 16ch Flex Speeder Large.
| Device ID | K121362 |
| 510k Number | K121362 |
| Device Name: | 1.5T 16CH FLEX SPEEDER LARGE |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NEOCOIL, LLC N27 W23910A PAUL RD. Pewaukee, WI 53072 |
| Contact | Steven Nichols |
| Correspondent | Steven Nichols NEOCOIL, LLC N27 W23910A PAUL RD. Pewaukee, WI 53072 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-07 |
| Decision Date | 2012-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856181003725 | K121362 | 000 |
| 00856181003176 | K121362 | 000 |
| 00856181003169 | K121362 | 000 |