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FDA 510(k)

ASCEND

K-Number: K091155 · 2009-09-03

ApplicantNeurometrix, Inc.
Decision Date2009-09-03
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ASCEND is the device name listed in this FDA 510(k) record. The listed applicant is Neurometrix, Inc.. It received FDA 510(k) clearance on 2009-09-03 under 510(k) number K091155. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCEND?

ASCEND is a medical device that received FDA 510(k) clearance on 2009-09-03. The listed applicant is Neurometrix, Inc.. The 510(k) number is K091155.

When did ASCEND receive FDA 510(k) clearance?

ASCEND received FDA 510(k) clearance on 2009-09-03, under 510(k) number K091155.

Who is the listed applicant for ASCEND?

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 ASCEND?

The FDA product code for ASCEND is BXN.

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Other records listing Neurometrix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K152954QuellK130919SENSUSK121816SENSUS ELECTRODEK121184SENSUSK083322NEUROMETRIX BIOAMPLIFIERK083818UNIVERSAL ELECTRODES

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Related Devices (Code: BXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213049STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd.K162086MultiStim ECOPAJUNK GmbH MedizintechnologieK153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorEasy Med Instrument Co., Ltd.K121743EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTINSunmed, LLCK111985MYOGUIDE SYSTEM MODEL 8008Intronix Technologies Corp.K110118STIMTRODE SINGLE USE NERVE STIMULATORXavant Technology (Pty), Ltd.

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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