DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM— 510(k) K061166

Name: FDA 510(k) clearance K061166
Creator: U.S. Food and Drug Administration
Published: 2006-08-15

Substantially Equivalent

Biowave Corporation

FDA 510(k) clearance K061166 for DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM, Substantially Equivalent on 2006-08-15. Applicant: Biowave Corporation. Device class: 2.

Clearance details

Applicant: Biowave Corporation
Product code: Code NHI
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2006-04-27
Decision date: 2006-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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