Clearance Summary
EDEC-100 received FDA 510(k) clearance under submission number K843443, sponsored by Electromed Intl., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1985-03-01.
- Submission: K843443
- Applicant / Sponsor: Electromed Intl., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1985-03-01
Classification & Regulation
This clearance is catalogued under FDA product code IZO and 21 CFR 892.1700, within the Radiology review panel as a Class I device.