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FDA 510(k)

PORTA 100HF

K-Number: K122697 · 2012-10-05

Decision Date2012-10-05
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PORTA 100HF is the device name listed in this FDA 510(k) record. The listed applicant is Job Corporation. It received FDA 510(k) clearance on 2012-10-05 under 510(k) number K122697. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTA 100HF?

PORTA 100HF is a medical device that received FDA 510(k) clearance on 2012-10-05. The listed applicant is Job Corporation. The 510(k) number is K122697.

When did PORTA 100HF receive FDA 510(k) clearance?

PORTA 100HF received FDA 510(k) clearance on 2012-10-05, under 510(k) number K122697.

Who is the listed applicant for PORTA 100HF?

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

What is the FDA product code for PORTA 100HF?

The FDA product code for PORTA 100HF is IZL.

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.

Related Devices (Code: IZL)

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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