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FDA 510(k)

Radial Compression Device

K-Number: K232577 · 2024-01-18

Decision Date2024-01-18
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Radial Compression Device is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Dizegens Medical Science Co.,Ltd. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K232577. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radial Compression Device?

Radial Compression Device is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Ningbo Dizegens Medical Science Co.,Ltd. The 510(k) number is K232577.

When did Radial Compression Device receive FDA 510(k) clearance?

Radial Compression Device received FDA 510(k) clearance on 2024-01-18, under 510(k) number K232577.

Who is the listed applicant for Radial Compression Device?

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

What is the FDA product code for Radial Compression Device?

The FDA product code for Radial Compression Device is DXC.

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.

Other records listing Ningbo Dizegens Medical Science 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.

Related Devices (Code: DXC)

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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