Clearance Summary
PORTABLE AUTOCLAVES received FDA 510(k) clearance under submission number K830931, sponsored by Arnold & Sons. 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 1983-07-27.
- Submission: K830931
- Applicant / Sponsor: Arnold & Sons
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 1983-07-27
Classification & Regulation
This clearance is catalogued under FDA product code FLE and 21 CFR 880.6880, within the General Hospital review panel as a Class II device.