Clearance Summary
AQUANOMICS, #HHU60 received FDA 510(k) clearance under submission number K813046, sponsored by Cooper-Hewitt Electric Co.. 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 1981-12-02.
- Submission: K813046
- Applicant / Sponsor: Cooper-Hewitt Electric Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6710
- Decision date: 1981-12-02
Classification & Regulation
This clearance is catalogued under FDA product code KMG and 21 CFR 880.6710, within the General Hospital review panel as a Class II device.