The following data is part of a premarket notification filed by Neocoil with the FDA for Neocoil 1.5t 8-channel Shoulder Array Coil.
| Device ID | K071311 |
| 510k Number | K071311 |
| Device Name: | NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NEOCOIL N27 W23910A PAUL RD. Pewaukee, WI 53072 |
| Contact | Brian Brown |
| Correspondent | Daniel W Lehtonen 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 | 2007-05-09 |
| Decision Date | 2007-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856181003046 | K071311 | 000 |