Clearance Summary
HOPE MODEL 126, AUTO/PROCES., DEN. FLM received FDA 510(k) clearance under submission number K800134, sponsored by Hope Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1980-05-02.
- Submission: K800134
- Applicant / Sponsor: Hope Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1840
- Decision date: 1980-05-02
Classification & Regulation
This clearance is catalogued under FDA product code IWZ and 21 CFR 892.1840, within the Radiology review panel as a Class I device.