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FDA 510(k)

FOCUS MIS SYSTEM

K-Number: K112643 · 2012-01-04

ApplicantL&K BIOMED Co., Ltd.
Decision Date2012-01-04
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FOCUS MIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2012-01-04 under 510(k) number K112643. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOCUS MIS SYSTEM?

FOCUS MIS SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-04. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K112643.

When did FOCUS MIS SYSTEM receive FDA 510(k) clearance?

FOCUS MIS SYSTEM received FDA 510(k) clearance on 2012-01-04, under 510(k) number K112643.

Who is the listed applicant for FOCUS MIS SYSTEM?

The FDA 510(k) record lists L&K BIOMED Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOCUS MIS SYSTEM?

The FDA product code for FOCUS MIS SYSTEM is NKB.

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Related Devices (Code: NKB)

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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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