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510(k) K200107

epoc Blood Analysis System by Epocal, Inc. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2020
Date Received
January 17, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type

Other clearances by Epocal, Inc.

  • K171247 — epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test (January 17, 2018)
  • K113726 — EPOC CHLORIDE TEST AND EPOC CREATININE TEST (October 5, 2012)
  • K093297 — EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (June 9, 2010)
  • K092849 — BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER (March 30, 2010)
  • K090109 — BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD (June 24, 2009)
  • K061597 — EPOC BLOOD ANALYSIS SYSTEM (September 27, 2006)

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