K211147 is an FDA 510(k) clearance for the ALGO 7i. 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 October 14, 2021, 178 days after receiving the submission on April 19, 2021.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 882.1900.
| 510(k) Number | K211147 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2021 |
| Decision Date | October 14, 2021 |
| Days to Decision | 178 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 |