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FDA 510(k)

NEUROMETRIX BIOAMPLIFIER

K-Number: K083322 · 2009-05-27

ApplicantNeurometrix, Inc.
Decision Date2009-05-27
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROMETRIX BIOAMPLIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Neurometrix, Inc.. It received FDA 510(k) clearance on 2009-05-27 under 510(k) number K083322. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROMETRIX BIOAMPLIFIER?

NEUROMETRIX BIOAMPLIFIER is a medical device that received FDA 510(k) clearance on 2009-05-27. The listed applicant is Neurometrix, Inc.. The 510(k) number is K083322.

When did NEUROMETRIX BIOAMPLIFIER receive FDA 510(k) clearance?

NEUROMETRIX BIOAMPLIFIER received FDA 510(k) clearance on 2009-05-27, under 510(k) number K083322.

Who is the listed applicant for NEUROMETRIX BIOAMPLIFIER?

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

What is the FDA product code for NEUROMETRIX BIOAMPLIFIER?

The FDA product code for NEUROMETRIX BIOAMPLIFIER is GWL.

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Other records listing Neurometrix, 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.

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