The following data is part of a premarket notification filed by Neocoil, Llc with the FDA for Headphones, Patient Alert, Standalone Interface.
| Device ID | K133670 |
| 510k Number | K133670 |
| Device Name: | HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | NEOCOIL, LLC N27 W23910A PAUL RD. Pewaukee, WI 53072 |
| Contact | Micheal Leigh |
| Correspondent | Micheal Leigh NEOCOIL, LLC N27 W23910A PAUL RD. Pewaukee, WI 53072 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-29 |
| Decision Date | 2014-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856181003732 | K133670 | 000 |
| 00856181003206 | K133670 | 000 |
| 00856181003213 | K133670 | 000 |
| 00856181003220 | K133670 | 000 |
| 00856181003367 | K133670 | 000 |
| 00856181003374 | K133670 | 000 |
| 00856181003398 | K133670 | 000 |
| 00856181003404 | K133670 | 000 |
| 00856181003411 | K133670 | 000 |
| 00856181003190 | K133670 | 000 |