FDA 510(k)

P-ARTIS

K-Number: K160611 · 2016-08-08

Decision Date2016-08-08

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

P-ARTIS is the device name listed in this FDA 510(k) record. The listed applicant is P-Cure, Ltd.. It received FDA 510(k) clearance on 2016-08-08 under 510(k) number K160611. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P-ARTIS?

P-ARTIS is a medical device that received FDA 510(k) clearance on 2016-08-08. The listed applicant is P-Cure, Ltd.. The 510(k) number is K160611.

When did P-ARTIS receive FDA 510(k) clearance?

P-ARTIS received FDA 510(k) clearance on 2016-08-08, under 510(k) number K160611.

Who is the listed applicant for P-ARTIS?

The FDA 510(k) record lists P-Cure, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P-ARTIS?

The FDA product code for P-ARTIS is JAK.

Other records listing P-Cure, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242418P-Cure Proton Therapy System (PPTS)K221996P-Cure Proton Beam Therapy System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.