Clearance Summary
DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E received FDA 510(k) clearance under submission number K942043, sponsored by Alm Surgical Equipment, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1994-07-13.
- Submission: K942043
- Applicant / Sponsor: Alm Surgical Equipment, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1994-07-13
Classification & Regulation
This clearance is catalogued under FDA product code FQO and 21 CFR 878.4960, within the General, Plastic Surgery review panel as a Class I device.