Cleared Traditional

DORO HEADREST SYSTEM

K001808 · Pro-Med Instruments GmbH · Neurology
Aug 2000
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K001808 is an FDA 510(k) clearance for the DORO HEADREST SYSTEM, a Holder, Head, Neurosurgical (skull Clamp) (Class II — Special Controls, product code HBL), submitted by Pro-Med Instruments GmbH (Roswell, US). The FDA issued a Cleared decision on August 4, 2000, 50 days after receiving the submission on June 15, 2000. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K001808 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2000
Decision Date August 04, 2000
Days to Decision 50 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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