Cadwell AmpliScan— 510(k) K161027

Substantially Equivalent

Cadwell Industries, Inc.

FDA 510(k) clearance K161027 for Cadwell AmpliScan, Substantially Equivalent on 2016-11-08. Applicant: Cadwell Industries, Inc.. Device class: 2.

Clearance details

Applicant: Cadwell Industries, Inc.
Product code: Code OMA
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2016-04-12
Decision date: 2016-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennewick, WA, 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.