Clearance Summary
PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 received FDA 510(k) clearance under submission number K002138, sponsored by Maersk Medical A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2000-08-29.
- Submission: K002138
- Applicant / Sponsor: Maersk Medical A/S
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2000-08-29
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.