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510(k) K932520

CALIBRATION GAS by Cryodyne Technologies, Inc. — Product Code BXK

K932520 is an FDA 510(k) premarket notification submitted by Cryodyne Technologies, Inc. for the device "CALIBRATION GAS". The FDA issued a decision of Substantially Equivalent on August 19, 1993. The device falls under product code BXK (Gas, Calibration (Specified Concentration)), a Class I device regulated under 21 CFR 868.6400. Cryodyne Technologies, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1993
Date Received
May 25, 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 Cryodyne Technologies, Inc.

  • K926464 — L.C.S.3000 (August 24, 1993)
  • K881465 — CRYOBIOLOGICAL FREEZER (April 21, 1988)
  • K881467 — MICROSCOPE STAGE HEATER (April 18, 1988)
  • K881466 — CELL-CULTURE SHAKER (April 18, 1988)
  • K860738 — CTC 30, 40, 1 LIQUID OXYGEN LITERS (August 6, 1986)

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