CADWELL SPIKE AND SEIZURE DETECTOR— 510(k) K140552

Substantially Equivalent

Cadwell

FDA 510(k) clearance K140552 for CADWELL SPIKE AND SEIZURE DETECTOR, Substantially Equivalent on 2014-07-23. Applicant: Cadwell. Device class: 2.

Clearance details

Applicant: Cadwell
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2014-03-04
Decision date: 2014-07-23
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.