The following data is part of a premarket notification filed by Neocoil, Llc with the FDA for Ecg Ct Gating Device.
| Device ID | K160350 |
| 510k Number | K160350 |
| Device Name: | ECG CT Gating Device |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-08 |
| Decision Date | 2016-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856181003336 | K160350 | 000 |
| 00856181003329 | K160350 | 000 |
| 00856181003312 | K160350 | 000 |