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510(k) K873587

BLOOD ANALYSIS GAS by National Welders — Product Code BXK

K873587 is an FDA 510(k) premarket notification submitted by National Welders for the device "BLOOD ANALYSIS GAS". The FDA issued a decision of Substantially Equivalent on October 30, 1987. 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
October 30, 1987
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

  • K873586 — LUNG DIFFUSION GAS (February 12, 1988)

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)
  • 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