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510(k) K133724

MINNCARE HD by Medivators, Inc. — Product Code NIH

K133724 is an FDA 510(k) premarket notification submitted by Medivators, Inc. for the device "MINNCARE HD". The FDA issued a decision of Substantially Equivalent on August 27, 2014. The device falls under product code NIH (Disinfectant, Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Medivators, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2014
Date Received
December 6, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Disinfectant, Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
HO
Submission Type

Disinfectant intended for reprocessing water purification systems for hemodialysis.

Other clearances by Medivators, Inc.

  • K231418 — ENDOGATOR™ Hybrid Irrigation Tubing (August 14, 2023)
  • K223040 — Endo SmartCap (March 1, 2023)
  • K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid (January 14, 2022)
  • K172677 — Advantage Plus Pass-Thru (December 19, 2017)
  • K162128 — Scope Buddy Plus Endoscope Flushing Aid (December 21, 2016)
  • K160846 — AmplifEYE (July 14, 2016)
  • K152394 — Rapicide PA High-Level Disinfectant Test Strips (March 11, 2016)
  • K151522 — DEFENDO Bronchoscopy Suction Valve (September 17, 2015)
  • K140753 — ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM (July 15, 2014)
  • K993042 — MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT (August 17, 2000)

FDA data resources