FDA 510(k)

NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX

K-Number: K031885 · 2003-08-21

Decision Date2003-08-21

Product CodeHBL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX is the device name listed in this FDA 510(k) record. The listed applicant is Image-Guided Neurologics, Inc.. It received FDA 510(k) clearance on 2003-08-21 under 510(k) number K031885. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX?

NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX is a medical device that received FDA 510(k) clearance on 2003-08-21. The listed applicant is Image-Guided Neurologics, Inc.. The 510(k) number is K031885.

When did NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX receive FDA 510(k) clearance?

NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX received FDA 510(k) clearance on 2003-08-21, under 510(k) number K031885.

Who is the listed applicant for NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX?

The FDA 510(k) record lists Image-Guided Neurologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX?

The FDA product code for NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX is HBL.

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Other records listing Image-Guided Neurologics, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.