EARPROBE— 510(k) K100661

Substantially Equivalent

Path Medical GmbH

FDA 510(k) clearance K100661 for EARPROBE, Substantially Equivalent on 2010-07-01. Applicant: Path Medical GmbH. Device class: 2.

Clearance details

Applicant: Path Medical GmbH
Product code: Code GWJ
Device class: Class 2
Regulation: 21 CFR 882.1900
Advisory panel: Neurology
Date received: 2010-03-08
Decision date: 2010-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Collins, CO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Path Medical GmbH

K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE2022-06-22
K133012 — SENTIERO2014-06-09
K131141 — EARPROBE2013-06-27

Recalls naming K100661

K-number listed on FDA's recall record

Z-0940-2026 — MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)Class II·Ongoing·PATH·20251106

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100661.

Data sourced from openFDA. This site is unofficial and independent of the FDA.