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FDA 510(k)

NSM-S15 SYSTEM

K-Number: K092237 · 2009-09-09

ApplicantNeusoft Medical Systems Co., Ltd.
Decision Date2009-09-09
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NSM-S15 SYSTEM 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 2009-09-09 under 510(k) number K092237. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NSM-S15 SYSTEM?

NSM-S15 SYSTEM is a medical device that received FDA 510(k) clearance on 2009-09-09. The listed applicant is Neusoft Medical Systems Co., Ltd.. The 510(k) number is K092237.

When did NSM-S15 SYSTEM receive FDA 510(k) clearance?

NSM-S15 SYSTEM received FDA 510(k) clearance on 2009-09-09, under 510(k) number K092237.

Who is the listed applicant for NSM-S15 SYSTEM?

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 NSM-S15 SYSTEM?

The FDA product code for NSM-S15 SYSTEM is LNH.

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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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