The following data is part of a premarket notification filed by Neocoil, Llc with the FDA for 1.5t 16ch Shoulder Coil, 3.0t 16ch Shoulder Coil.
| Device ID | K201101 |
| 510k Number | K201101 |
| Device Name: | 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NeoCoil, LLC N27 W23910A Paul Rd. Pewaukee, WI 53072 |
| Contact | Katie Gonzalez |
| Correspondent | Katie Gonzalez 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 | 2020-04-24 |
| Decision Date | 2020-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856181003923 | K201101 | 000 |
| 00856181003930 | K201101 | 000 |
| 00856181003909 | K201101 | 000 |
| 00856181003961 | K201101 | 000 |
| 00856181003954 | K201101 | 000 |
| 00856181003947 | K201101 | 000 |
| 00856181003916 | K201101 | 000 |