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510(k) K873586

LUNG DIFFUSION GAS by National Welders — Product Code BXK

K873586 is an FDA 510(k) premarket notification submitted by National Welders for the device "LUNG DIFFUSION GAS". The FDA issued a decision of Substantially Equivalent on February 12, 1988. The device falls under product code BXK (Gas, Calibration (Specified Concentration)), a Class I device regulated under 21 CFR 868.6400. National Welders has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1988
Date Received
September 4, 1987
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 National Welders

  • K873587 — BLOOD ANALYSIS GAS (October 30, 1987)

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