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FDA 510(k)

P-ART, MODEL 001

K-Number: K092424 · 2010-03-05

ApplicantP-Cure, Ltd.
Decision Date2010-03-05
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

P-ART, MODEL 001 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 2010-03-05 under 510(k) number K092424. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P-ART, MODEL 001?

P-ART, MODEL 001 is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is P-Cure, Ltd.. The 510(k) number is K092424.

When did P-ART, MODEL 001 receive FDA 510(k) clearance?

P-ART, MODEL 001 received FDA 510(k) clearance on 2010-03-05, under 510(k) number K092424.

Who is the listed applicant for P-ART, MODEL 001?

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-ART, MODEL 001?

The FDA product code for P-ART, MODEL 001 is IYE.

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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 SystemK160611P-ARTIS

Related Devices (Code: IYE)

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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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