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FDA 510(k)

NEUROSYSTEMS 1TM MONITOR

K-Number: K050702 · 2005-05-17

ApplicantNeurosystems, LLC
Decision Date2005-05-17
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROSYSTEMS 1TM MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Neurosystems, LLC. It received FDA 510(k) clearance on 2005-05-17 under 510(k) number K050702. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROSYSTEMS 1TM MONITOR?

NEUROSYSTEMS 1TM MONITOR is a medical device that received FDA 510(k) clearance on 2005-05-17. The listed applicant is Neurosystems, LLC. The 510(k) number is K050702.

When did NEUROSYSTEMS 1TM MONITOR receive FDA 510(k) clearance?

NEUROSYSTEMS 1TM MONITOR received FDA 510(k) clearance on 2005-05-17, under 510(k) number K050702.

Who is the listed applicant for NEUROSYSTEMS 1TM MONITOR?

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

What is the FDA product code for NEUROSYSTEMS 1TM MONITOR?

The FDA product code for NEUROSYSTEMS 1TM MONITOR is GWM.

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Related Devices (Code: GWM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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