Clearance Summary
PORTABLE BREAST COMPRESSION DEVICE received FDA 510(k) clearance under submission number K003775, sponsored by Pem Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-01-12.
- Submission: K003775
- Applicant / Sponsor: Pem Technologies
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 2001-01-12
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.