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FDA 510(k)

I-PORT

K-Number: K052389 · 2005-09-09

Decision Date2005-09-09
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I-PORT is the device name listed in this FDA 510(k) record. The listed applicant is Patton Medical Devices. It received FDA 510(k) clearance on 2005-09-09 under 510(k) number K052389. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-PORT?

I-PORT is a medical device that received FDA 510(k) clearance on 2005-09-09. The listed applicant is Patton Medical Devices. The 510(k) number is K052389.

When did I-PORT receive FDA 510(k) clearance?

I-PORT received FDA 510(k) clearance on 2005-09-09, under 510(k) number K052389.

Who is the listed applicant for I-PORT?

The FDA 510(k) record lists Patton Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-PORT?

The FDA product code for I-PORT is FOZ.

Related Devices (Code: FOZ)

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.

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.

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