FDA 510(k)

MR Conditional Cup Electrode, MR Conditional Webb Electrode

K-Nummer: K172503 · 2017-12-01

AntragstellerRhythmlink International, LLC

Entscheidungsdatum2017-12-01

ProduktcodeGXY

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

MR Conditional Cup Electrode, MR Conditional Webb 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 2017-12-01 under 510(k) number K172503. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the MR Conditional Cup Electrode, MR Conditional Webb Electrode?

MR Conditional Cup Electrode, MR Conditional Webb Electrode is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K172503.

When did MR Conditional Cup Electrode, MR Conditional Webb Electrode receive FDA 510(k) clearance?

MR Conditional Cup Electrode, MR Conditional Webb Electrode received FDA 510(k) clearance on 2017-12-01, under 510(k) number K172503.

Who is the listed applicant for MR Conditional Cup Electrode, MR Conditional Webb 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 MR Conditional Cup Electrode, MR Conditional Webb Electrode?

The FDA product code for MR Conditional Cup Electrode, MR Conditional Webb Electrode is GXY.

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Verwandte Geräte (Code: GXY)

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