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)

510(k) number: K242852
Device name: 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)
Applicant: Inomed Medizintechnik GmbH DE
Product code: ETN — Stimulator, Nerve
Decision date: 2025-06-13
Date received: 2024-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Ear, Nose, Throat

PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K242852.pdf

Official FDA record: K242852

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.