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510(k) K841089

LINEAR CLOUD TONOMETER by Linear Tonometers, Inc. — Product Code LCH

K841089 is an FDA 510(k) premarket notification submitted by Linear Tonometers, Inc. for the device "LINEAR CLOUD TONOMETER". The FDA issued a decision of Substantially Equivalent on May 22, 1984. 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
May 22, 1984
Date Received
March 13, 1984
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)
  • 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