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FDA 510(k)

IDEAL

K-Number: K132428 · 2013-12-20

Decision Date2013-12-20
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IDEAL is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Ideal Medical Science & Technology Co., LT. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K132428. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDEAL?

IDEAL is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Jiangsu Ideal Medical Science & Technology Co., LT. The 510(k) number is K132428.

When did IDEAL receive FDA 510(k) clearance?

IDEAL received FDA 510(k) clearance on 2013-12-20, under 510(k) number K132428.

Who is the listed applicant for IDEAL?

The FDA 510(k) record lists Jiangsu Ideal Medical Science & Technology Co., LT as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDEAL?

The FDA product code for IDEAL is HSB.

Related Clinical Trials

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.

Related Devices (Code: HSB)

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.

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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