Clearance Summary
SLENDAIR 4000 COMPRESSION SYSTEM received FDA 510(k) clearance under submission number K994057, sponsored by Medical Compression Systems (Dbn) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2000-03-03.
- Submission: K994057
- Applicant / Sponsor: Medical Compression Systems (Dbn) , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 2000-03-03
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.