ASCEND— 510(k) K091155

Substantially Equivalent

Neurometrix, Inc.

FDA 510(k) clearance K091155 for ASCEND, Substantially Equivalent on 2009-09-03. Applicant: Neurometrix, Inc..

Clearance details

Applicant: Neurometrix, Inc.
Product code: Code BXN
Advisory panel: Anesthesiology
Date received: 2009-04-21
Decision date: 2009-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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Adverse events under product code BXN

product code BXN

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.