Cleared Traditional

DORO QR3 Headrest System (Aluminum)

K203505 · Pro-Med Instruments GmbH · Neurology
Mar 2021
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K203505 is an FDA 510(k) clearance for the DORO QR3 Headrest System (Aluminum), 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 March 29, 2021, 119 days after receiving the submission on November 30, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K203505 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2020
Decision Date March 29, 2021
Days to Decision 119 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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