K150804 is an FDA 510(k) clearance for the QBioScan. This device is classified as a Device, Galvanic Skin Response Measurement (Class II - Special Controls, product code GZO).
Submitted by Medeia, Inc. (Miami, US). The FDA issued a Cleared decision on October 19, 2015, 207 days after receiving the submission on March 26, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1540.
| 510(k) Number | K150804 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2015 |
| Decision Date | October 19, 2015 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZO — Device, Galvanic Skin Response Measurement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1540 |