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FDA 510(k)

HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS

K-Number: K123263 · 2013-04-04

ApplicantEckert & Ziegler Bebig GmbH
Decision Date2013-04-04
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS is the device name listed in this FDA 510(k) record. The listed applicant is Eckert & Ziegler Bebig GmbH. It received FDA 510(k) clearance on 2013-04-04 under 510(k) number K123263. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS?

HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS is a medical device that received FDA 510(k) clearance on 2013-04-04. The listed applicant is Eckert & Ziegler Bebig GmbH. The 510(k) number is K123263.

When did HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS receive FDA 510(k) clearance?

HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS received FDA 510(k) clearance on 2013-04-04, under 510(k) number K123263.

Who is the listed applicant for HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS?

The FDA 510(k) record lists Eckert & Ziegler Bebig GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS?

The FDA product code for HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS is MUJ.

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Related Devices (Code: MUJ)

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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