510(k) K091874

INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 by Inomed Medizintechnik GmbH — Product Code ETN

K091874 is an FDA 510(k) premarket notification submitted by Inomed Medizintechnik GmbH for the device "INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656". The FDA issued a decision of Substantially Equivalent on November 18, 2009. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Inomed Medizintechnik GmbH has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2009
Date Received
June 23, 2009
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