K220139 is an FDA 510(k) clearance for the QScreen. This device is classified as a Stimulator, Auditory, Evoked Response (Class II - Special Controls, product code GWJ).
Submitted by Path Medical GmbH (Germering, DE). The FDA issued a Cleared decision on August 3, 2022, 197 days after receiving the submission on January 18, 2022.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 882.1900.
| 510(k) Number | K220139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2022 |
| Decision Date | August 03, 2022 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | GWJ - Stimulator, Auditory, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1900 |