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FDA 510(k)

NEUROMAP WITH NEURO 100

K-Number: K002773 · 2000-10-23

ApplicantRadionics, Inc.
Decision Date2000-10-23
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROMAP WITH NEURO 100 is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 2000-10-23 under 510(k) number K002773. 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 NEUROMAP WITH NEURO 100?

NEUROMAP WITH NEURO 100 is a medical device that received FDA 510(k) clearance on 2000-10-23. The listed applicant is Radionics, Inc.. The 510(k) number is K002773.

When did NEUROMAP WITH NEURO 100 receive FDA 510(k) clearance?

NEUROMAP WITH NEURO 100 received FDA 510(k) clearance on 2000-10-23, under 510(k) number K002773.

Who is the listed applicant for NEUROMAP WITH NEURO 100?

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

What is the FDA product code for NEUROMAP WITH NEURO 100?

The FDA product code for NEUROMAP WITH NEURO 100 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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