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510(k) K000103

AVL OPTI R ANALYZER by Avl Scientific Corp. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2000
Date Received
January 13, 2000
Clearance Type
Traditional
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 Avl Scientific Corp.

  • K001632 — OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 (June 19, 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)
  • K961458 — AVL 9180 ELECTROLYTE ANALYZER (June 12, 1996)

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