Clearance Summary
GEMS-H received FDA 510(k) clearance under submission number K213452, sponsored by Samsung Electronics Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2022-04-21.
- Submission: K213452
- Applicant / Sponsor: Samsung Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3480
- Decision date: 2022-04-21
Classification & Regulation
This clearance is catalogued under FDA product code PHL and 21 CFR 890.3480, within the Physical Medicine review panel as a Class II device.