The following data is part of a premarket notification filed by Creavo Medical Technologies, Ltd. with the FDA for Creavo Vitalscan Magnetocardiograph.
| Device ID | K170154 |
| 510k Number | K170154 |
| Device Name: | Creavo Vitalscan Magnetocardiograph |
| Classification | Electrocardiograph |
| Applicant | Creavo Medical Technologies, Ltd. 2020 House, Siskin Drive, Middlemarch Business Park Coventry, GB Cv3 4fj |
| Contact | David Dimambro |
| Correspondent | Sharon L. Timberlake Halloran Consulting Group, LLC 266 Summer Street 8th Floor Boston, MA 02210 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-18 |
| Decision Date | 2017-10-12 |
| Summary: | summary |