510(k) K122040
K122040 is an FDA 510(k) premarket notification submitted by Invotec International, Inc. for the device "INVOTEC LARYNGEAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on October 31, 2013. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Invotec International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2013
- Date Received
- July 12, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- EN
- Submission Type