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510(k) K802379

HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER by American Instrument Co. — Product Code LCH

K802379 is an FDA 510(k) premarket notification submitted by American Instrument Co. for the device "HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code LCH (Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical), a Class I device regulated under 21 CFR 862.1660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
September 30, 1980
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 for product code LCH

  • K922386 — RNA MEDICAL TONOMETER (June 26, 1992)
  • K904163 — CLINICAL BLOOD GAS MIXTURES (November 1, 1990)
  • K900819 — BLOOD GAS CALIBRATION STANDARD (April 25, 1990)
  • K862958 — AMR RESEARCH TONOMETER (November 24, 1986)
  • K841089 — LINEAR CLOUD TONOMETER (May 22, 1984)
  • K801599 — CORNING 184 BLOOD GAS TONOMETER (August 20, 1980)
  • K781417 — PRECISION GAS MIXER (September 20, 1978)
  • K781386 — EBS 775 TONOMETER (September 14, 1978)

FDA data resources