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FDA 510(k)

KOSTEC MEDICAL GRADE LDC MONITORS

K-Number: K123944 · 2013-09-05

ApplicantKostec Co., Ltd.
Decision Date2013-09-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KOSTEC MEDICAL GRADE LDC MONITORS is the device name listed in this FDA 510(k) record. The listed applicant is Kostec Co., Ltd.. It received FDA 510(k) clearance on 2013-09-05 under 510(k) number K123944. 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 KOSTEC MEDICAL GRADE LDC MONITORS?

KOSTEC MEDICAL GRADE LDC MONITORS is a medical device that received FDA 510(k) clearance on 2013-09-05. The listed applicant is Kostec Co., Ltd.. The 510(k) number is K123944.

When did KOSTEC MEDICAL GRADE LDC MONITORS receive FDA 510(k) clearance?

KOSTEC MEDICAL GRADE LDC MONITORS received FDA 510(k) clearance on 2013-09-05, under 510(k) number K123944.

Who is the listed applicant for KOSTEC MEDICAL GRADE LDC MONITORS?

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

What is the FDA product code for KOSTEC MEDICAL GRADE LDC MONITORS?

The FDA product code for KOSTEC MEDICAL GRADE LDC MONITORS is LLZ.

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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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