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FDA 510(k)

EMG RECORDING ELECTRODE ASSEMBLY

K-Number: K120342 · 2012-06-22

ApplicantRhythmlink International, LLC
Decision Date2012-06-22
Product CodeIKT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EMG RECORDING ELECTRODE ASSEMBLY 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 2012-06-22 under 510(k) number K120342. The device is classified under product code IKT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMG RECORDING ELECTRODE ASSEMBLY?

EMG RECORDING ELECTRODE ASSEMBLY is a medical device that received FDA 510(k) clearance on 2012-06-22. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K120342.

When did EMG RECORDING ELECTRODE ASSEMBLY receive FDA 510(k) clearance?

EMG RECORDING ELECTRODE ASSEMBLY received FDA 510(k) clearance on 2012-06-22, under 510(k) number K120342.

Who is the listed applicant for EMG RECORDING ELECTRODE ASSEMBLY?

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 EMG RECORDING ELECTRODE ASSEMBLY?

The FDA product code for EMG RECORDING ELECTRODE ASSEMBLY is IKT.

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Related Devices (Code: IKT)

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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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