K233649 is an FDA 510(k) clearance for the ALGO Pro Newborn Hearing Screener (ALGO Pro). This device is classified as a Stimulator, Auditory, Evoked Response (Class II - Special Controls, product code GWJ).
Submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on March 8, 2024, 115 days after receiving the submission on November 14, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 882.1900.
| 510(k) Number | K233649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2023 |
| Decision Date | March 08, 2024 |
| Days to Decision | 115 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 |