NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX

Holder, Head, Neurosurgical (skull Clamp)

IMAGE-GUIDED NEUROLOGICS, INC.

The following data is part of a premarket notification filed by Image-guided Neurologics, Inc. with the FDA for Navigus Passive Head Restraint System, Model Hr-xxx.

Pre-market Notification Details

• Device ID: K031885
• 510k Number: K031885
• Device Name: NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
• Classification: Holder, Head, Neurosurgical (skull Clamp)
• Applicant: IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. Melbourne, FL 32935
• Contact: David M Lee
• Correspondent: David M Lee; IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. Melbourne, FL 32935
• Product Code: HBL
• CFR Regulation Number: 882.4460 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-06-18
• Decision Date: 2003-08-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994755544	K031885	000
00613994755537	K031885	000
00613994289391	K031885	000
00643169919396	K031885	000
00873263007778	K031885	000
00873263007884	K031885	000