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FDA 510(k)

SUPEROPEN 0.23T, MODEL NAM-P023A

K-Number: K033315 · 2003-10-29

ApplicantNeusoft Digital Medical Systems Co., Ltd.
Decision Date2003-10-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SUPEROPEN 0.23T, MODEL NAM-P023A is the device name listed in this FDA 510(k) record. The listed applicant is Neusoft Digital Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2003-10-29 under 510(k) number K033315. 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 SUPEROPEN 0.23T, MODEL NAM-P023A?

SUPEROPEN 0.23T, MODEL NAM-P023A is a medical device that received FDA 510(k) clearance on 2003-10-29. The listed applicant is Neusoft Digital Medical Systems Co., Ltd.. The 510(k) number is K033315.

When did SUPEROPEN 0.23T, MODEL NAM-P023A receive FDA 510(k) clearance?

SUPEROPEN 0.23T, MODEL NAM-P023A received FDA 510(k) clearance on 2003-10-29, under 510(k) number K033315.

Who is the listed applicant for SUPEROPEN 0.23T, MODEL NAM-P023A?

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

What is the FDA product code for SUPEROPEN 0.23T, MODEL NAM-P023A?

The FDA product code for SUPEROPEN 0.23T, MODEL NAM-P023A is LNH.

Related Clinical Trials

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Other records listing Neusoft Digital Medical Systems Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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