Aquanomics, #SP36SF
510(k) K813045
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813045 | Date2 Dec 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KMG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6710
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
This device is a water purifier using ultraviolet technology, classified as a medical device for general hospital use. It is designed to purify water through ultraviolet irradiation, as indicated by its device name and classification in the openFDA data.
The device was granted FDA 510(k) clearance under K813045 on December 2, 1981, and is classified as a Class II medical device with product code KMG. It is supplied as a reusable system intended for use in general hospital settings, with no claims of sterility, single-use status, MRI safety, or specific sizes provided in the data.