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FDA 510(k)

NUBIC AND RABEA DEVICES

K-Number: K082848 · 2009-07-24

ApplicantSignus Medizintechnik GmbH
Decision Date2009-07-24
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NUBIC AND RABEA DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2009-07-24 under 510(k) number K082848. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUBIC AND RABEA DEVICES?

NUBIC AND RABEA DEVICES is a medical device that received FDA 510(k) clearance on 2009-07-24. The listed applicant is Signus Medizintechnik GmbH. The 510(k) number is K082848.

When did NUBIC AND RABEA DEVICES receive FDA 510(k) clearance?

NUBIC AND RABEA DEVICES received FDA 510(k) clearance on 2009-07-24, under 510(k) number K082848.

Who is the listed applicant for NUBIC AND RABEA DEVICES?

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

What is the FDA product code for NUBIC AND RABEA DEVICES?

The FDA product code for NUBIC AND RABEA DEVICES is ODP.

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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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