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FDA 510(k)

CUTANEOUS ELECTRODE

K-Number: K052188 · 2005-08-23

ApplicantRhythmlink International, LLC
Decision Date2005-08-23
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CUTANEOUS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Rhythmlink International, LLC. It received FDA 510(k) clearance on 2005-08-23 under 510(k) number K052188. 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 CUTANEOUS ELECTRODE?

CUTANEOUS ELECTRODE is a medical device that received FDA 510(k) clearance on 2005-08-23. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K052188.

When did CUTANEOUS ELECTRODE receive FDA 510(k) clearance?

CUTANEOUS ELECTRODE received FDA 510(k) clearance on 2005-08-23, under 510(k) number K052188.

Who is the listed applicant for CUTANEOUS ELECTRODE?

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

What is the FDA product code for CUTANEOUS ELECTRODE?

The FDA product code for CUTANEOUS ELECTRODE 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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