Submission Details
| 510(k) Number | K050162 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 25, 2005 |
| Decision Date | March 03, 2005 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
Mar 2005
Decision
37d
Days
Class 2
Risk
About This 510(k) Submission
K050162 is an FDA 510(k) clearance for the CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 3, 2005, 37 days after receiving the submission on January 25, 2005. 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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