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FDA 510(k)

LOSPA IS ACP System

K-Number: K161641 · 2017-01-05

ApplicantCorentec Co., Ltd.
Decision Date2017-01-05
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOSPA IS ACP System is the device name listed in this FDA 510(k) record. The listed applicant is Corentec Co., Ltd.. It received FDA 510(k) clearance on 2017-01-05 under 510(k) number K161641. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOSPA IS ACP System?

LOSPA IS ACP System is a medical device that received FDA 510(k) clearance on 2017-01-05. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K161641.

When did LOSPA IS ACP System receive FDA 510(k) clearance?

LOSPA IS ACP System received FDA 510(k) clearance on 2017-01-05, under 510(k) number K161641.

Who is the listed applicant for LOSPA IS ACP System?

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

What is the FDA product code for LOSPA IS ACP System?

The FDA product code for LOSPA IS ACP System is KWQ.

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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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