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FDA 510(k)

MANUJET III

K-Number: K112783 · 2011-12-22

ApplicantVBM Medizintechnik GmbH
Decision Date2011-12-22
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MANUJET III is the device name listed in this FDA 510(k) record. The listed applicant is VBM Medizintechnik GmbH. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K112783. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANUJET III?

MANUJET III is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is VBM Medizintechnik GmbH. The 510(k) number is K112783.

When did MANUJET III receive FDA 510(k) clearance?

MANUJET III received FDA 510(k) clearance on 2011-12-22, under 510(k) number K112783.

Who is the listed applicant for MANUJET III?

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

What is the FDA product code for MANUJET III?

The FDA product code for MANUJET III is BTL.

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Other records listing VBM Medizintechnik GmbH as applicant

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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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