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510(k) K955013

NOVA CO-OXIMETER ANALYZER by Nova Biomedical Corp. — Product Code GLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1996
Date Received
November 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter To Measure Hemoglobin
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type

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  • K060345 — NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS (April 28, 2006)
  • K041016 — NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS (May 7, 2004)

Other clearances for product code GLY

  • K050014 — HEMONIR TM (May 5, 2005)
  • K993104 — STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND (December 2, 1999)
  • K952725 — MULTICHECK (February 20, 1996)
  • K895466 — AVL MODEL 912 CO-OXYLITE (November 6, 1989)