510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813046Substantially Equivalent

Aquanomics, #Hhu60

Cooper-Hewitt Electric Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813046 is the FDA 510(k) clearance record for AQUANOMICS, #HHU60, a class II device, cleared for Cooper-Hewitt Electric Co. on under FDA product code KMG (Purifier, Water, Ultraviolet, Medical). FDA records list 8 510(k) clearances for Cooper-Hewitt Electric Co., from to . As of , FDA records show no recalls naming K813046.

Clearance record

Decision date
Received
(35 days to decision)
Product code
KMG Purifier, Water, Ultraviolet, Medical
Regulation
21 CFR 880.6710
Device class
Class II
Review panel
General Hospital
Applicant
Cooper-Hewitt Electric Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KMG

Trailing 12 months

FDA records hold no clearances under product code KMG in the trailing twelve months.

FDA records show no clearances under product code KMG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260