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FDA 510(k)

HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM

K-Number: K102900 · 2012-03-21

ApplicantHei, Inc.
Decision Date2012-03-21
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hei, Inc.. It received FDA 510(k) clearance on 2012-03-21 under 510(k) number K102900. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM?

HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-21. The listed applicant is Hei, Inc.. The 510(k) number is K102900.

When did HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM receive FDA 510(k) clearance?

HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM received FDA 510(k) clearance on 2012-03-21, under 510(k) number K102900.

Who is the listed applicant for HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM?

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

What is the FDA product code for HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM?

The FDA product code for HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM is LGZ.

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Related Devices (Code: LGZ)

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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.

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