The following data is part of a premarket notification filed by Neocoil, Llc with the FDA for 3t 16ch Flex Speeder, Medium , 3t 16ch Flex Speeder, Large.
| Device ID | K141832 |
| 510k Number | K141832 |
| Device Name: | 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NEOCOIL, LLC N27 W23910A PAUL RD. Pewaukee, WI 53072 |
| Contact | Michael Leigh |
| Correspondent | Michael Leigh 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 | 2014-07-07 |
| Decision Date | 2014-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856181003251 | K141832 | 000 |
| 00856181003244 | K141832 | 000 |