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FDA 510(k)

MAGNA TEK ESU-400

K-Number: K003471 · 2000-11-20

ApplicantHuttinger Medizintechnik GmbH & CO KG
Decision Date2000-11-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MAGNA TEK ESU-400 is the device name listed in this FDA 510(k) record. The listed applicant is Huttinger Medizintechnik GmbH & CO KG. It received FDA 510(k) clearance on 2000-11-20 under 510(k) number K003471. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNA TEK ESU-400?

MAGNA TEK ESU-400 is a medical device that received FDA 510(k) clearance on 2000-11-20. The listed applicant is Huttinger Medizintechnik GmbH & CO KG. The 510(k) number is K003471.

When did MAGNA TEK ESU-400 receive FDA 510(k) clearance?

MAGNA TEK ESU-400 received FDA 510(k) clearance on 2000-11-20, under 510(k) number K003471.

Who is the listed applicant for MAGNA TEK ESU-400?

The FDA 510(k) record lists Huttinger Medizintechnik GmbH & CO KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGNA TEK ESU-400?

The FDA product code for MAGNA TEK ESU-400 is GEI.

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 Huttinger Medizintechnik GmbH & CO KG 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.

K944928PY30, PY60, PY80

Related Devices (Code: GEI)

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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