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FDA 510(k)

NAVIGATION PROBES

K-Number: K082404 · 2009-02-25

ApplicantWe Sense, Ltd.
Decision Date2009-02-25
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVIGATION PROBES is the device name listed in this FDA 510(k) record. The listed applicant is We Sense, Ltd.. It received FDA 510(k) clearance on 2009-02-25 under 510(k) number K082404. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGATION PROBES?

NAVIGATION PROBES is a medical device that received FDA 510(k) clearance on 2009-02-25. The listed applicant is We Sense, Ltd.. The 510(k) number is K082404.

When did NAVIGATION PROBES receive FDA 510(k) clearance?

NAVIGATION PROBES received FDA 510(k) clearance on 2009-02-25, under 510(k) number K082404.

Who is the listed applicant for NAVIGATION PROBES?

The FDA 510(k) record lists We Sense, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIGATION PROBES?

The FDA product code for NAVIGATION PROBES is GZL.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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