The following data is part of a premarket notification filed by Vektor Medical, Inc. with the FDA for Vektor Computational Ecg Mapping System (vmap).
| Device ID | K211546 |
| 510k Number | K211546 |
| Device Name: | Vektor Computational ECG Mapping System (vMap) |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Vektor Medical, Inc. 7875 Sitio Abeto Carlsbad, CA 92009 |
| Contact | Mike Monko |
| Correspondent | Michael J Billig Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-19 |
| Decision Date | 2021-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007954177 | K211546 | 000 |
| 00860007954108 | K211546 | 000 |
| 00860007954122 | K211546 | 000 |
| 00860007954115 | K211546 | 000 |