Navigus Passive Head Restraint System, Model Hr-Xxx

FDA 510(k) K031885 · Image-Guided Neurologics, Inc.

Substantially Equivalent

510(k) numberK031885

Submission

Device name
Navigus Passive Head Restraint System, Model Hr-Xxx
Applicant
Image-Guided Neurologics, Inc.
Melbourne, FL, US
Received
June 18, 2003
Decision date
August 21, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HBL – Holder, Head, Neurosurgical (Skull Clamp)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4460
Specialty
Neurology

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Questions and answers

When was Navigus Passive Head Restraint System, Model Hr-Xxx cleared by the FDA?

Navigus Passive Head Restraint System, Model Hr-Xxx (K031885) received a 510(k) decision of Substantially Equivalent on August 21, 2003, 64 days after the submission was received.

What is the product code of K031885?

The FDA product code is HBL – Holder, Head, Neurosurgical (Skull Clamp), a Class II (moderate risk) device regulated under 21 CFR 882.4460.