FDA 510(k)

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

Numéro K : K161318 · 2017-03-20

DemandeurTedan Surgical Innovations, LLC

Date de décision2017-03-20

Code produitGZT

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is the device name listed in this FDA 510(k) record. The listed applicant is Tedan Surgical Innovations, LLC. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K161318. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems?

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Tedan Surgical Innovations, LLC. The 510(k) number is K161318.

When did Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems receive FDA 510(k) clearance?

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems received FDA 510(k) clearance on 2017-03-20, under 510(k) number K161318.

Who is the listed applicant for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems?

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

What is the FDA product code for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems?

The FDA product code for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is GZT.

Essais cliniques associés

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Source officielle

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