Clearance Summary
3M MEDICAL DIAGNOSTIC VIDEOCASSETTE received FDA 510(k) clearance under submission number K931604, sponsored by 3M Health Care, 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 1993-07-21.
- Submission: K931604
- Applicant / Sponsor: 3M Health Care, Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1840
- Decision date: 1993-07-21
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.