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510(k) K924795

BLOOD GAS MIXTURE by Gulf States Airgas — Product Code BXK

K924795 is an FDA 510(k) premarket notification submitted by Gulf States Airgas for the device "BLOOD GAS MIXTURE". The FDA issued a decision of Substantially Equivalent on December 17, 1992. The device falls under product code BXK (Gas, Calibration (Specified Concentration)), a Class I device regulated under 21 CFR 868.6400. Gulf States Airgas has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1992
Date Received
September 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas, Calibration (Specified Concentration)
Device Class
Class I
Regulation Number
868.6400
Review Panel
AN
Submission Type

Other clearances by Gulf States Airgas

  • K924796 — LUNG DIFFUSION GAS MIXTURE (December 17, 1992)

Other clearances for product code BXK

  • K954804 — LUNG DIFFUSION MIXTURES (January 25, 1996)
  • K954803 — BLOOD GAS MIXTURES (January 25, 1996)
  • K954542 — LUNG DIFFUSION MIXTURE (December 22, 1995)
  • K952838 — MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES (September 19, 1995)
  • K953934 — MED-TECH LUNG DIFFUSION MIXTURE (September 18, 1995)
  • K953208 — MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES (July 20, 1995)
  • K944998 — CALIBRATION GAS (February 3, 1995)
  • K944812 — CLINICAL BLOOD GAS MIXTURE (February 1, 1995)
  • K942866 — CLINICAL BLOOD GAS MIXTURE (September 1, 1994)
  • K932874 — BLOOD GAS MIXTURE (January 27, 1994)

FDA data resources