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510(k) K023567

STAT PROFILE PHOX PLUS L ANALYZER by Nova Biomedical Corp. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2002
Date Received
October 23, 2002
Clearance Type
Abbreviated
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

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  • K063821 — NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM (January 24, 2007)
  • K061830 — STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ (November 1, 2006)
  • K060345 — NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS (April 28, 2006)
  • K041016 — NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS (May 7, 2004)

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