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510(k) K900819

BLOOD GAS CALIBRATION STANDARD by Cryogenic Rare Gas Laboratories, Inc. — Product Code LCH

K900819 is an FDA 510(k) premarket notification submitted by Cryogenic Rare Gas Laboratories, Inc. for the device "BLOOD GAS CALIBRATION STANDARD". The FDA issued a decision of Substantially Equivalent on April 25, 1990. 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
April 25, 1990
Date Received
February 21, 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 for product code LCH

  • K922386 — RNA MEDICAL TONOMETER (June 26, 1992)
  • K904163 — CLINICAL BLOOD GAS MIXTURES (November 1, 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)

FDA data resources