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FDA 510(k)

MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035

K-Number: K061132 · 2006-05-24

ApplicantNeusoft Medical Systems Co., Ltd.
Decision Date2006-05-24
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 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 2006-05-24 under 510(k) number K061132. 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 MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035?

MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 is a medical device that received FDA 510(k) clearance on 2006-05-24. The listed applicant is Neusoft Medical Systems Co., Ltd.. The 510(k) number is K061132.

When did MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 receive FDA 510(k) clearance?

MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 received FDA 510(k) clearance on 2006-05-24, under 510(k) number K061132.

Who is the listed applicant for MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035?

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 MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035?

The FDA product code for MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 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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