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510(k) K954542

LUNG DIFFUSION MIXTURE by Liquid Technology Corp. — Product Code BXK

K954542 is an FDA 510(k) premarket notification submitted by Liquid Technology Corp. for the device "LUNG DIFFUSION MIXTURE". The FDA issued a decision of Substantially Equivalent on December 22, 1995. The device falls under product code BXK (Gas, Calibration (Specified Concentration)), a Class I device regulated under 21 CFR 868.6400. Liquid Technology Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1995
Date Received
September 29, 1995
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 Liquid Technology Corp.

  • K954546 — BLOOD GAS MIXTURE (December 28, 1995)
  • K954544 — LASER GAS MIXTURE (October 30, 1995)

Other clearances for product code BXK

  • K954804 — LUNG DIFFUSION MIXTURES (January 25, 1996)
  • K954803 — BLOOD GAS MIXTURES (January 25, 1996)
  • 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)
  • K935311 — CLINICAL BLOOD GAS (December 22, 1993)

FDA data resources