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510(k) K012029

REMEDY MODEL 2Z12 by Apollo Corp. — Product Code KMG

K012029 is an FDA 510(k) premarket notification submitted by Apollo Corp. for the device "REMEDY MODEL 2Z12". The FDA issued a decision of Substantially Equivalent on December 31, 2001. The device falls under product code KMG (Purifier, Water, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2001
Date Received
June 28, 2001
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 for product code KMG

  • K832288 — HEMOGLOBINOMETER (September 1, 1983)
  • K831253 — LANCER HEMOGLOBIN ANALYZER REAGENTS (May 9, 1983)
  • K813048 — AQUANOMICS, #MP2SF (December 2, 1981)
  • K813047 — AQUANOMICS, MINI 60L (December 2, 1981)
  • K813045 — AQUANOMICS, #SP36SF (December 2, 1981)
  • K813046 — AQUANOMICS, #HHU60 (December 2, 1981)
  • K813049 — AQUANOMICS, #HHU100 (December 2, 1981)
  • K813050 — AQUANOMICS, #MP4SF (December 2, 1981)

FDA data resources