Clearance Summary
COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT received FDA 510(k) clearance under submission number K860023, sponsored by Atrium Medical Corp.. 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 1986-01-10.
- Submission: K860023
- Applicant / Sponsor: Atrium Medical Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1986-01-10
Classification & Regulation
This clearance is catalogued under FDA product code KDQ and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.