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510(k) K935311

CLINICAL BLOOD GAS by Acetylene Gas Co. — Product Code BXK

K935311 is an FDA 510(k) premarket notification submitted by Acetylene Gas Co. for the device "CLINICAL BLOOD GAS". The FDA issued a decision of Substantially Equivalent on December 22, 1993. The device falls under product code BXK (Gas, Calibration (Specified Concentration)), a Class I device regulated under 21 CFR 868.6400. Acetylene Gas Co. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1993
Date Received
November 2, 1993
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 Acetylene Gas Co.

  • K935309 — LUNG DIFFUSION (September 27, 1994)
  • K935310 — MEDICAL LASER MIXTURE (December 23, 1993)

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