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FDA 510(k)

METALYZER, MODEL 2; METALYZER, MODEL 3

K-Number: K993641 · 2000-12-14

ApplicantCortex Biophysik GmbH
Decision Date2000-12-14
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

METALYZER, MODEL 2; METALYZER, MODEL 3 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 2000-12-14 under 510(k) number K993641. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METALYZER, MODEL 2; METALYZER, MODEL 3?

METALYZER, MODEL 2; METALYZER, MODEL 3 is a medical device that received FDA 510(k) clearance on 2000-12-14. The listed applicant is Cortex Biophysik GmbH. The 510(k) number is K993641.

When did METALYZER, MODEL 2; METALYZER, MODEL 3 receive FDA 510(k) clearance?

METALYZER, MODEL 2; METALYZER, MODEL 3 received FDA 510(k) clearance on 2000-12-14, under 510(k) number K993641.

Who is the listed applicant for METALYZER, MODEL 2; METALYZER, MODEL 3?

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 METALYZER, MODEL 2; METALYZER, MODEL 3?

The FDA product code for METALYZER, MODEL 2; METALYZER, MODEL 3 is BTY.

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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.

K001631CORTEX METAMAX

Related Devices (Code: BTY)

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

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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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