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FDA 510(k)

SUNSPOTS PRE-GELLED SURFACE ELECTRODES

K-Number: K062198 · 2006-12-19

ApplicantAxon Systems, Inc.
Decision Date2006-12-19
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SUNSPOTS PRE-GELLED SURFACE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Axon Systems, Inc.. It received FDA 510(k) clearance on 2006-12-19 under 510(k) number K062198. 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 SUNSPOTS PRE-GELLED SURFACE ELECTRODES?

SUNSPOTS PRE-GELLED SURFACE ELECTRODES is a medical device that received FDA 510(k) clearance on 2006-12-19. The listed applicant is Axon Systems, Inc.. The 510(k) number is K062198.

When did SUNSPOTS PRE-GELLED SURFACE ELECTRODES receive FDA 510(k) clearance?

SUNSPOTS PRE-GELLED SURFACE ELECTRODES received FDA 510(k) clearance on 2006-12-19, under 510(k) number K062198.

Who is the listed applicant for SUNSPOTS PRE-GELLED SURFACE ELECTRODES?

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

What is the FDA product code for SUNSPOTS PRE-GELLED SURFACE ELECTRODES?

The FDA product code for SUNSPOTS PRE-GELLED SURFACE ELECTRODES is GXY.

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Other records listing Axon Systems, Inc. as applicant

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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Related Devices (Code: GXY)

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Official Source

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