DORO LUCENT® IXI And IMRI Headrest System

Holder, Head, Neurosurgical (skull Clamp)

Pro Med Instruments GmbH

The following data is part of a premarket notification filed by Pro Med Instruments Gmbh with the FDA for Doro Lucent® Ixi And Imri Headrest System.

Pre-market Notification Details

• Device ID: K191740
• 510k Number: K191740
• Device Name: DORO LUCENT® IXI And IMRI Headrest System
• Classification: Holder, Head, Neurosurgical (skull Clamp)
• Applicant: Pro Med Instruments GmbH Boetzinger Str. 38 Freiburg, DE 79111
• Contact: Sandra Untenberger
• Correspondent: Sandra Untenberger; Pro Med Instruments GmbH Boetzinger Str. 38 Freiburg, DE 79111
• Product Code: HBL
• CFR Regulation Number: 882.4460 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-07-01
• Decision Date: 2020-02-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04250435534045	K191740	000
04250435537503	K191740	000
04250435520390	K191740	000
04250435520420	K191740	000
04250435532126	K191740	000
04250435534052	K191740	000
04250435534137	K191740	000
04250435534151	K191740	000
04250435534168	K191740	000
04250435534175	K191740	000
04250435534182	K191740	000
04250435517789	K191740	000
04250435517796	K191740	000
04250435533994	K191740	000
04250435539378	K191740	000