NAVIGATION PROBES— 510(k) K082404

Substantially Equivalent

We Sense, Ltd.

FDA 510(k) clearance K082404 for NAVIGATION PROBES, Substantially Equivalent on 2009-02-25. Applicant: We Sense, Ltd.. Device class: 2.

Clearance details

Applicant: We Sense, Ltd.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2008-08-21
Decision date: 2009-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nazareth, IL

Download summary PDF View on FDA.gov ↗

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