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FDA 510(k)

I_OPEN 0.4T

K-Number: K090433 · 2009-03-25

ApplicantBeijing Wandong Medical Equipment Co., Ltd.
Decision Date2009-03-25
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I_OPEN 0.4T is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Wandong Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2009-03-25 under 510(k) number K090433. 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 I_OPEN 0.4T?

I_OPEN 0.4T is a medical device that received FDA 510(k) clearance on 2009-03-25. The listed applicant is Beijing Wandong Medical Equipment Co., Ltd.. The 510(k) number is K090433.

When did I_OPEN 0.4T receive FDA 510(k) clearance?

I_OPEN 0.4T received FDA 510(k) clearance on 2009-03-25, under 510(k) number K090433.

Who is the listed applicant for I_OPEN 0.4T?

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

What is the FDA product code for I_OPEN 0.4T?

The FDA product code for I_OPEN 0.4T is LNH.

Other records listing Beijing Wandong Medical Equipment 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.

K090873I OPEN 0.5T

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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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