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FDA 510(k)

PIUR tUS Infinity

K-Number: K240036 · 2024-09-20

ApplicantPiur Imaging GmbH
Decision Date2024-09-20
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PIUR tUS Infinity is the device name listed in this FDA 510(k) record. The listed applicant is Piur Imaging GmbH. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K240036. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIUR tUS Infinity?

PIUR tUS Infinity is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Piur Imaging GmbH. The 510(k) number is K240036.

When did PIUR tUS Infinity receive FDA 510(k) clearance?

PIUR tUS Infinity received FDA 510(k) clearance on 2024-09-20, under 510(k) number K240036.

Who is the listed applicant for PIUR tUS Infinity?

The FDA 510(k) record lists Piur Imaging GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIUR tUS Infinity?

The FDA product code for PIUR tUS Infinity is QIH.

Related Clinical Trials

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.

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Other records listing Piur Imaging GmbH 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.

K250484PIUR tUS inside

Related Devices (Code: QIH)

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.

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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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