K091874 is an FDA 510(k) clearance for the INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Inomed Medizintechnik GmbH (Crofton, US). The FDA issued a Cleared decision on November 18, 2009, 148 days after receiving the submission on June 23, 2009.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K091874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2009 |
| Decision Date | November 18, 2009 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETN - Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |