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510(k) K152553

CueSee Hypoxic by Eurotrol B.V. — Product Code JJS

K152553 is an FDA 510(k) premarket notification submitted by Eurotrol B.V. for the device "CueSee Hypoxic". The FDA issued a decision of Substantially Equivalent on April 22, 2016. The device falls under product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Eurotrol B.V. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2016
Date Received
September 8, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controls For Blood-Gases, (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Eurotrol B.V.

  • K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (November 15, 2019)
  • K182744 — HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High (February 1, 2019)
  • K131595 — EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM (July 26, 2013)
  • K121467 — EUROTROL HEMATOCRIT CONTROL (May 10, 2013)
  • K121468 — EUROTROL GAS-ISE METABOLITES (June 22, 2012)
  • K060215 — ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 (March 24, 2006)

Other clearances for product code JJS

  • K150226 — Hematocrit and Metabolite QUALICHECK (May 13, 2015)
  • K130415 — HIGH METABOLITE QUALICHECK (March 26, 2013)
  • K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL (March 15, 2013)
  • K033063 — MISSION CONTROLS (December 12, 2003)
  • K022525 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 (August 15, 2002)
  • K022529 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, A (August 15, 2002)
  • K003242 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 (November 30, 2000)
  • K003239 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 (November 30, 2000)
  • K002865 — LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 (September 25, 2000)
  • K002866 — LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 (September 25, 2000)

FDA data resources