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FDA 510(k)

NEUCOLONCARE

K-Number: K110077 · 2011-01-28

ApplicantNeusoft Medical Systems Co., Ltd.
Decision Date2011-01-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEUCOLONCARE is the device name listed in this FDA 510(k) record. The listed applicant is Neusoft Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2011-01-28 under 510(k) number K110077. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUCOLONCARE?

NEUCOLONCARE is a medical device that received FDA 510(k) clearance on 2011-01-28. The listed applicant is Neusoft Medical Systems Co., Ltd.. The 510(k) number is K110077.

When did NEUCOLONCARE receive FDA 510(k) clearance?

NEUCOLONCARE received FDA 510(k) clearance on 2011-01-28, under 510(k) number K110077.

Who is the listed applicant for NEUCOLONCARE?

The FDA 510(k) record lists Neusoft Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUCOLONCARE?

The FDA product code for NEUCOLONCARE is LLZ.

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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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