FDA 510(k)

TheraVision Ultrasound Ablation System and ACOUSTx Applicators

Numéro K : K150019 · 2016-01-13

Date de décision2016-01-13

Code produitNTB

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

TheraVision Ultrasound Ablation System and ACOUSTx Applicators is the device name listed in this FDA 510(k) record. The listed applicant is Acoustic Medsystems, Inc.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K150019. The device is classified under product code NTB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the TheraVision Ultrasound Ablation System and ACOUSTx Applicators?

TheraVision Ultrasound Ablation System and ACOUSTx Applicators is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Acoustic Medsystems, Inc.. The 510(k) number is K150019.

When did TheraVision Ultrasound Ablation System and ACOUSTx Applicators receive FDA 510(k) clearance?

TheraVision Ultrasound Ablation System and ACOUSTx Applicators received FDA 510(k) clearance on 2016-01-13, under 510(k) number K150019.

Who is the listed applicant for TheraVision Ultrasound Ablation System and ACOUSTx Applicators?

The FDA 510(k) record lists Acoustic Medsystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TheraVision Ultrasound Ablation System and ACOUSTx Applicators?

The FDA product code for TheraVision Ultrasound Ablation System and ACOUSTx Applicators is NTB.

Essais cliniques associés

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Source officielle

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