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510(k) K242852

ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) by Inomed Medizintechnik GmbH — Product Code ETN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 13, 2025
Date Received: September 20, 2024
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

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K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (January 7, 2022)
K152505 — C2 NerveMonitor System (February 1, 2016)
K111647 — C2 NERVEMONITOR SYSTEM WITH ACCESSORIES (October 6, 2011)
K091874 — INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 (November 18, 2009)
K042208 — ISIS MER SYSTEM/ELEKTA MER SYSTEM (March 18, 2005)
K910972 — WALTER GRAPHTEK (October 2, 1991)

Other clearances for product code ETN

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K233001 — Bioscope Neuromonitor Device (December 13, 2024)
K241917 — EARP Nerve Cuff Electrode (July 31, 2024)
K232888 — Disposable Laryngeal Electrodes (December 21, 2023)
K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotrache (October 26, 2023)
K230853 — EARP Nerve Cuff Electrode (October 6, 2023)
K231580 — NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (August 30, 2023)
K223254 — C2 Xplore (January 27, 2023)
K212164 — Mapping Suction Probe (November 11, 2022)