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FDA 510(k)

CORTEX METAMAX

K-Number: K001631 · 2001-02-22

ApplicantCortex Biophysik GmbH
Decision Date2001-02-22
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CORTEX METAMAX is the device name listed in this FDA 510(k) record. The listed applicant is Cortex Biophysik GmbH. It received FDA 510(k) clearance on 2001-02-22 under 510(k) number K001631. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORTEX METAMAX?

CORTEX METAMAX is a medical device that received FDA 510(k) clearance on 2001-02-22. The listed applicant is Cortex Biophysik GmbH. The 510(k) number is K001631.

When did CORTEX METAMAX receive FDA 510(k) clearance?

CORTEX METAMAX received FDA 510(k) clearance on 2001-02-22, under 510(k) number K001631.

Who is the listed applicant for CORTEX METAMAX?

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

What is the FDA product code for CORTEX METAMAX?

The FDA product code for CORTEX METAMAX is BZC.

Related Clinical Trials

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Other records listing Cortex Biophysik 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.

K993641METALYZER, MODEL 2; METALYZER, MODEL 3

Related Devices (Code: BZC)

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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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