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FDA 510(k)

NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)

K-Number: K083371 · 2009-12-08

ApplicantNatus Medical, Inc.
Decision Date2009-12-08
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical, Inc.. It received FDA 510(k) clearance on 2009-12-08 under 510(k) number K083371. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)?

NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) is a medical device that received FDA 510(k) clearance on 2009-12-08. The listed applicant is Natus Medical, Inc.. The 510(k) number is K083371.

When did NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) receive FDA 510(k) clearance?

NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) received FDA 510(k) clearance on 2009-12-08, under 510(k) number K083371.

Who is the listed applicant for NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)?

The FDA 510(k) record lists Natus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)?

The FDA product code for NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) is GWF.

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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.

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