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FDA 510(k)

HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500

K-Number: K960732 · 1996-04-15

ApplicantPhysiometrix, Inc.
Decision Date1996-04-15
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 is the device name listed in this FDA 510(k) record. The listed applicant is Physiometrix, Inc.. It received FDA 510(k) clearance on 1996-04-15 under 510(k) number K960732. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500?

HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Physiometrix, Inc.. The 510(k) number is K960732.

When did HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 receive FDA 510(k) clearance?

HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 received FDA 510(k) clearance on 1996-04-15, under 510(k) number K960732.

Who is the listed applicant for HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500?

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

What is the FDA product code for HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500?

The FDA product code for HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 is GXY.

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Related Devices (Code: GXY)

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Official Source

View on FDA Database →

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

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