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FDA 510(k)

External Drainage System

K-Number: K221694 · 2023-02-09

Decision Date2023-02-09
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

External Drainage System is the device name listed in this FDA 510(k) record. The listed applicant is Jmed(Shenzhen) Technology Limited. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K221694. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the External Drainage System?

External Drainage System is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is Jmed(Shenzhen) Technology Limited. The 510(k) number is K221694.

When did External Drainage System receive FDA 510(k) clearance?

External Drainage System received FDA 510(k) clearance on 2023-02-09, under 510(k) number K221694.

Who is the listed applicant for External Drainage System?

The FDA 510(k) record lists Jmed(Shenzhen) Technology Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for External Drainage System?

The FDA product code for External Drainage System is JXG.

Related Devices (Code: JXG)

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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