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FDA 510(k)

RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT

K-Number: K112435 · 2011-09-22

ApplicantRhythmlink International, LLC
Decision Date2011-09-22
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT 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 2011-09-22 under 510(k) number K112435. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT?

RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT is a medical device that received FDA 510(k) clearance on 2011-09-22. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K112435.

When did RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT receive FDA 510(k) clearance?

RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT received FDA 510(k) clearance on 2011-09-22, under 510(k) number K112435.

Who is the listed applicant for RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT?

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 MONOPOLAR STIMULATING INSTRUMENT?

The FDA product code for RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT is ETN.

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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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