The following data is part of a premarket notification filed by Medeia, Inc. with the FDA for Qbioscan.
| Device ID | K150804 |
| 510k Number | K150804 |
| Device Name: | QBioScan |
| Classification | Device, Galvanic Skin Response Measurement |
| Applicant | MEDEIA, INC. 80 S. W. 8TH ST. SUITE 200 Miami, FL 33130 |
| Contact | Slav Danev |
| Correspondent | Daniel Lehtonen COMPLIANCE AND REGULATORY SERVICES LLC 3771 SOUTHBROOK DR Dayton, OH 45430 |
| Product Code | GZO |
| CFR Regulation Number | 882.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-26 |
| Decision Date | 2015-10-19 |
| Summary: | summary |