Aquanomics Mini 60L

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

510(k) Number

K813047 ↗

FDA Product Code

KMG

Device Class

Class II

Regulation

21 CFR Part 880.6710

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Aquanomics #HHU100

  Class II

  FDA 510(k) K813049 Active Cleared 2 Dec 1981

• 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, #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

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• What is the Aquanomics Mini 60L used for in medical settings?

  The Aquanomics Mini 60L is a water purifier device that uses ultraviolet technology and is intended for use in general hospital settings to ensure clean water for medical applications.

• How is the Aquanomics Mini 60L supplied and what are its model specifications?

  The device is supplied with the model number MINI 60L and is classified as a Class II medical device. It is manufactured by Cooper-Hewitt Electric Co. and regulated under product code KMG.

• Is the Aquanomics Mini 60L a single-use device or can it be reused?

  The device information does not specify whether it is designed for single-use or reuse. However, as a water purifier using UV technology for medical applications, it is likely designed for repeated use with proper maintenance.

• What regulatory approvals does the Aquanomics Mini 60L have?

  The Aquanomics Mini 60L received FDA 510(k) clearance on December 2, 1981, with K number K813047. It is registered with registration number 2028411 and has an FEI number of 3027509245.

• How should the Aquanomics Mini 60L be stored when not in use?

  The device data does not provide specific storage instructions. As a medical device using UV technology, it should be stored in a clean, dry environment according to the manufacturer's guidelines to maintain its functionality and safety.