FDA 510(k) Premarket Notification K230241: Jumong General

Submission Details & Decision

Normalized public record details for 510(k) notification K230241.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K230241

Applicant / Sponsor

Sg Healthcare Co, Ltd.

Device Name

Jumong General

Product Code

KPR

Decision Date

2023-02-23

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Special

Third Party Flag

Date Received

2023-01-30

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