Aquanomics #HHU100

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K813049 ↗

FDA Product Code

KMG

Device Class

Class II

Regulation

21 CFR Part 880.6710

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Spertilite Phototherapy Lamp

  Class II

  FDA 510(k) K862608 Active Cleared 6 Aug 1986

• Aquanomics, #HHU60

  Class II

  FDA 510(k) K813046 Active Cleared 2 Dec 1981

• Aquanomics, #MP4SF

  Class II

  FDA 510(k) K813050 Active Cleared 2 Dec 1981

• Aquanomics Mini 60L

  Class II

  FDA 510(k) K813047 Active Cleared 2 Dec 1981

• Aquanomics, #SP36SF

  Class II

  FDA 510(k) K813045 Active Cleared 2 Dec 1981

• Air Care Air Sanitizer

  Class II

  FDA 510(k) K860132 Active Cleared 13 Jan 1987

See all devices from Cooper-Hewitt Electric Co. →

• What is the primary purpose of the Aquanomics #HHU100?

  The Aquanomics #HHU100 is a medical ultraviolet water purifier specifically engineered for general hospital use to assist in maintaining water purification standards within clinical environments.

• What is the regulatory status of this water purification system?

  The Aquanomics #HHU100 has received FDA 510(k) clearance and is classified as a class 2 medical device under regulation number 880.6710, indicating it has been found substantially equivalent to legally marketed predicate devices.

• Who is the manufacturer of the Aquanomics #HHU100?

  This device is manufactured by Cooper-Hewitt Electric Co., located in McHenry, Illinois, which is responsible for the production and regulatory filing of the system.