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FDA 510(k)

RHYTHMLINK DISC ELECTRODES

K-Number: K061148 · 2006-05-10

ApplicantRhythmlink International, LLC
Decision Date2006-05-10
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RHYTHMLINK DISC ELECTRODES 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 2006-05-10 under 510(k) number K061148. 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 RHYTHMLINK DISC ELECTRODES?

RHYTHMLINK DISC ELECTRODES is a medical device that received FDA 510(k) clearance on 2006-05-10. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K061148.

When did RHYTHMLINK DISC ELECTRODES receive FDA 510(k) clearance?

RHYTHMLINK DISC ELECTRODES received FDA 510(k) clearance on 2006-05-10, under 510(k) number K061148.

Who is the listed applicant for RHYTHMLINK DISC ELECTRODES?

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 RHYTHMLINK DISC ELECTRODES?

The FDA product code for RHYTHMLINK DISC ELECTRODES is 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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