LogoFDA 510(k) Search
K Number
K001808
Device Name
DORO HEADREST SYSTEM
Manufacturer
PRO-MED INSTRUMENTS GMBH
Date Cleared
2000-08-04

(50 days)

Product Code
HBL
Regulation Number
882.4460
Type
Traditional
Panel
Neurology
Reference & Predicate Devices
N/A
Predicate For
K032331,K063494,K083803
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 882.4460 Neurosurgical head holder (skull clamp).

(a)
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.(b)
Classification. Class II (performance standards).