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510(k) K944998

CALIBRATION GAS by Sunox, Inc. — Product Code BXK

K944998 is an FDA 510(k) premarket notification submitted by Sunox, Inc. for the device "CALIBRATION GAS". The FDA issued a decision of Substantially Equivalent on February 3, 1995. The device falls under product code BXK (Gas, Calibration (Specified Concentration)), a Class I device regulated under 21 CFR 868.6400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1995
Date Received
October 13, 1994
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 for product code BXK

  • K954803 — BLOOD GAS MIXTURES (January 25, 1996)
  • K954804 — LUNG DIFFUSION 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)
  • K944812 — CLINICAL BLOOD GAS MIXTURE (February 1, 1995)
  • K942866 — CLINICAL BLOOD GAS MIXTURE (September 1, 1994)
  • K932874 — BLOOD GAS MIXTURE (January 27, 1994)
  • K935311 — CLINICAL BLOOD GAS (December 22, 1993)

FDA data resources