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510(k) K904163

CLINICAL BLOOD GAS MIXTURES by Norco, Inc. — Product Code LCH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1990
Date Received
September 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Norco, Inc.

  • K911471 — LUNG DIFFUSION GAS MIXTURES (June 18, 1991)
  • K904162 — CARBON DIOXIDE FLOWTHROUGH LASER MIXTURES (October 19, 1990)

Other clearances for product code LCH

  • K922386 — RNA MEDICAL TONOMETER (June 26, 1992)
  • K900819 — BLOOD GAS CALIBRATION STANDARD (April 25, 1990)
  • K862958 — AMR RESEARCH TONOMETER (November 24, 1986)
  • K841089 — LINEAR CLOUD TONOMETER (May 22, 1984)
  • K802379 — HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER (October 31, 1980)
  • K801599 — CORNING 184 BLOOD GAS TONOMETER (August 20, 1980)
  • K781417 — PRECISION GAS MIXER (September 20, 1978)
  • K781386 — EBS 775 TONOMETER (September 14, 1978)