FDA 510(k)

MB 11

K-Number: K011746 · 2001-08-24

Decision Date2001-08-24

Product CodeGWJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MB 11 is the device name listed in this FDA 510(k) record. The listed applicant is Maico Diagnostic GmbH. It received FDA 510(k) clearance on 2001-08-24 under 510(k) number K011746. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MB 11?

MB 11 is a medical device that received FDA 510(k) clearance on 2001-08-24. The listed applicant is Maico Diagnostic GmbH. The 510(k) number is K011746.

When did MB 11 receive FDA 510(k) clearance?

MB 11 received FDA 510(k) clearance on 2001-08-24, under 510(k) number K011746.

Who is the listed applicant for MB 11?

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

What is the FDA product code for MB 11?

The FDA product code for MB 11 is GWJ.

Related Devices (Code: GWJ)

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.