Submission Details
| 510(k) Number | K091874 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656
Nov 2009
Decision
148d
Days
Class 2
Risk
About This 510(k) Submission
K091874 is an FDA 510(k) clearance for the INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656, 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 review panel. Regulated under 21 CFR 874.1820.
Device Classification
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.1820 |
Manufacturer
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