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510(k) K922386

RNA MEDICAL TONOMETER by Bionostics, Inc. — Product Code LCH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1992
Date Received
May 20, 1992
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

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Other clearances for product code LCH

  • 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)
  • 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)