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510(k) K895466

AVL MODEL 912 CO-OXYLITE by Avl Scientific Corp. — Product Code GLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1989
Date Received
September 11, 1989
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

Other clearances by Avl Scientific Corp.

  • K001632 — OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 (June 19, 2000)
  • K000103 — AVL OPTI R ANALYZER (March 20, 2000)
  • K993837 — AVL OPTI CRITICAL CARE ANALYZER (December 16, 1999)
  • K990092 — AVL OMNI MODULAR ANALYZER (January 29, 1999)
  • K984299 — AVL OPTI CRITICAL CARE ANALYZER (December 11, 1998)
  • K974784 — AVL OPTI CRITICAL CARE ANALYZER (February 24, 1998)
  • K974822 — AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL (January 22, 1998)
  • K972733 — AVL OMNI ANALYZER (September 9, 1997)
  • K972673 — AVL 9181 ELECTROLYTE ANALYZER (August 20, 1997)
  • K963964 — AVL COMPACT 3 PH/BLOOD GAS ANALYZER (November 29, 1996)

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)
  • K955013 — NOVA CO-OXIMETER ANALYZER (April 25, 1996)
  • K952725 — MULTICHECK (February 20, 1996)