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510(k) K813050

AQUANOMICS, #MP4SF by Cooper-Hewitt Electric Co. — Product Code KMG

K813050 is an FDA 510(k) premarket notification submitted by Cooper-Hewitt Electric Co. for the device "AQUANOMICS, #MP4SF". The FDA issued a decision of Substantially Equivalent on December 2, 1981. The device falls under product code KMG (Purifier, Water, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6710. Cooper-Hewitt Electric Co. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1981
Date Received
October 28, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Purifier, Water, Ultraviolet, Medical
Device Class
Class II
Regulation Number
880.6710
Review Panel
HO
Submission Type

Other clearances by Cooper-Hewitt Electric Co.

  • K860132 — AIR CARE AIR SANITIZER (January 13, 1987)
  • K862608 — SPERTILITE PHOTOTHERAPY LAMP (August 6, 1986)
  • K813046 — AQUANOMICS, #HHU60 (December 2, 1981)
  • K813045 — AQUANOMICS, #SP36SF (December 2, 1981)
  • K813049 — AQUANOMICS, #HHU100 (December 2, 1981)
  • K813047 — AQUANOMICS, MINI 60L (December 2, 1981)
  • K813048 — AQUANOMICS, #MP2SF (December 2, 1981)

Other clearances for product code KMG

  • K012029 — REMEDY MODEL 2Z12 (December 31, 2001)
  • K832288 — HEMOGLOBINOMETER (September 1, 1983)
  • K831253 — LANCER HEMOGLOBIN ANALYZER REAGENTS (May 9, 1983)
  • K813047 — AQUANOMICS, MINI 60L (December 2, 1981)
  • K813048 — AQUANOMICS, #MP2SF (December 2, 1981)
  • K813046 — AQUANOMICS, #HHU60 (December 2, 1981)
  • K813045 — AQUANOMICS, #SP36SF (December 2, 1981)
  • K813049 — AQUANOMICS, #HHU100 (December 2, 1981)

FDA data resources