Cleared Traditional

DORO QR3 XTom Headholder System

K191979 · Pro-Med Instruments GmbH · Neurology
Oct 2019
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K191979 is an FDA 510(k) clearance for the DORO QR3 XTom Headholder System, a Holder, Head, Neurosurgical (skull Clamp) (Class II — Special Controls, product code HBL), submitted by Pro-Med Instruments GmbH (Freiburg, DE). The FDA issued a Cleared decision on October 22, 2019, 90 days after receiving the submission on July 24, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K191979 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2019
Decision Date October 22, 2019
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBL — Holder, Head, Neurosurgical (skull Clamp)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4460

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