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FDA 510(k)

WAVESTATE NEUROMONITOR

K-Number: K092625 · 2010-06-29

ApplicantWavestate, Inc.
Decision Date2010-06-29
Product CodeORT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WAVESTATE NEUROMONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Wavestate, Inc.. It received FDA 510(k) clearance on 2010-06-29 under 510(k) number K092625. The device is classified under product code ORT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAVESTATE NEUROMONITOR?

WAVESTATE NEUROMONITOR is a medical device that received FDA 510(k) clearance on 2010-06-29. The listed applicant is Wavestate, Inc.. The 510(k) number is K092625.

When did WAVESTATE NEUROMONITOR receive FDA 510(k) clearance?

WAVESTATE NEUROMONITOR received FDA 510(k) clearance on 2010-06-29, under 510(k) number K092625.

Who is the listed applicant for WAVESTATE NEUROMONITOR?

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

What is the FDA product code for WAVESTATE NEUROMONITOR?

The FDA product code for WAVESTATE NEUROMONITOR is ORT.

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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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