K970555 is an FDA 510(k) clearance for the IL0292 DP ECHOPORT. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Smith (Crofton, US). The FDA issued a Cleared decision on March 17, 1997, 32 days after receiving the submission on February 13, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K970555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1997 |
| Decision Date | March 17, 1997 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | EWO — Audiometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1050 |