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510(k) K162421

IntelliCartTM System by Dornoch Medical Systems — Product Code JCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2016
Date Received
August 30, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Dornoch Medical Systems

  • K190789 — IntelliCartTM System (April 24, 2019)
  • K172481 — IntelliCart System (September 14, 2017)
  • K133786 — DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART (March 21, 2014)
  • K123188 — DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CA (March 4, 2013)
  • K081047 — TRANSPOSAL ULTRA SYSTEMS (April 29, 2008)

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  • K182950 — Acare Suction Unit (August 23, 2019)
  • K190789 — IntelliCartTM System (April 24, 2019)
  • K190105 — ZOOM Aspiration Pump (February 21, 2019)
  • K180115 — TWBM Pump (July 24, 2018)
  • K181398 — DV-300 Aspirator (July 23, 2018)