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510(k) K882210

MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES by Linde Div. Union Carbide Corp. — Product Code BXK

K882210 is an FDA 510(k) premarket notification submitted by Linde Div. Union Carbide Corp. for the device "MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES". The FDA issued a decision of Substantially Equivalent on June 21, 1988. The device falls under product code BXK (Gas, Calibration (Specified Concentration)), a Class I device regulated under 21 CFR 868.6400. Linde Div. Union Carbide Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1988
Date Received
May 26, 1988
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 Linde Div. Union Carbide Corp.

  • K882208 — MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES (August 3, 1988)
  • K882209 — MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES (August 2, 1988)
  • K832143 — MARK III OXYGEN WALKER SYS. RESERVOIR (August 26, 1983)
  • K823582 — OXYGEN CONCENTRATOR UCC-100 (January 5, 1983)
  • K821841 — MEDIGAS SUCTION/DRAINAGE EQUIPMENT (July 2, 1982)

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