The following data is part of a premarket notification filed by Cgx, Llc with the FDA for Quick-20m.
| Device ID | K203331 |
| 510k Number | K203331 |
| Device Name: | Quick-20m |
| Classification | Amplifier, Physiological Signal |
| Applicant | CGX, LLC 8445 Camino Sante Fe, Suite 104 San Diego, CA 92121 |
| Contact | Spencer Linton |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-11-12 |
| Decision Date | 2021-05-20 |