Home / 510(k) Clearances / K953934

510(k) K953934

MED-TECH LUNG DIFFUSION MIXTURE by Medical Technical Gases Inc.. — Product Code BXK

K953934 is an FDA 510(k) premarket notification submitted by Medical Technical Gases Inc.. for the device "MED-TECH LUNG DIFFUSION MIXTURE". The FDA issued a decision of Substantially Equivalent on September 18, 1995. The device falls under product code BXK (Gas, Calibration (Specified Concentration)), a Class I device regulated under 21 CFR 868.6400. Medical Technical Gases Inc.. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1995
Date Received
August 18, 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 Medical Technical Gases Inc..

  • K953935 — MED-TECH CLINICAL BLOOD GAS (November 20, 1995)
  • K953933 — MED-TECH LASER GAS MIXTURE (September 1, 1995)

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)
  • 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