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510(k) K781417

PRECISION GAS MIXER by Medicor USA , Ltd. — Product Code LCH

K781417 is an FDA 510(k) premarket notification submitted by Medicor USA , Ltd. for the device "PRECISION GAS MIXER". The FDA issued a decision of Substantially Equivalent on September 20, 1978. 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. Medicor USA , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1978
Date Received
August 16, 1978
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 Medicor USA , Ltd.

  • K861994 — MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM (July 18, 1986)
  • K861995 — MODEL RS-3 RADIOGRAPHIC STAND (June 19, 1986)
  • K860025 — MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR (May 7, 1986)
  • K850761 — MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C (September 19, 1985)
  • K851358 — MODEL BION 2/TYPE 90 ROOM IONIZER (July 1, 1985)
  • K851094 — MODEL BION 1/TYPE 1084T CAR IONIZER (June 19, 1985)
  • K843335 — FLOOR MOUNTED X-RAY TUBESTAND (November 27, 1984)
  • K840227 — UROLIX-3 UROLOGICAL TABLE (March 23, 1984)
  • K840225 — C-ARM CEILING CRANE FT-2 (March 22, 1984)
  • K840226 — MOTOR TILTED EXAM. TABLE UV-56 (March 16, 1984)

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)
  • K802379 — HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER (October 31, 1980)
  • K801599 — CORNING 184 BLOOD GAS TONOMETER (August 20, 1980)
  • K781386 — EBS 775 TONOMETER (September 14, 1978)

FDA data resources