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FDA 510(k)

Jumong General

K-Number: K230241 · 2023-02-23

Decision Date2023-02-23
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Jumong General is the device name listed in this FDA 510(k) record. The listed applicant is Sg Healthcare Co, Ltd.. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K230241. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Jumong General?

Jumong General is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Sg Healthcare Co, Ltd.. The 510(k) number is K230241.

When did Jumong General receive FDA 510(k) clearance?

Jumong General received FDA 510(k) clearance on 2023-02-23, under 510(k) number K230241.

Who is the listed applicant for Jumong General?

The FDA 510(k) record lists Sg Healthcare Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Jumong General?

The FDA product code for Jumong General is KPR.

Other records listing Sg Healthcare 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: KPR)

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.