Home / 510(k) Clearances / K860738

510(k) K860738

CTC 30, 40, 1 LIQUID OXYGEN LITERS by Cryodyne Technologies, Inc. — Product Code BYJ

K860738 is an FDA 510(k) premarket notification submitted by Cryodyne Technologies, Inc. for the device "CTC 30, 40, 1 LIQUID OXYGEN LITERS". The FDA issued a decision of Substantially Equivalent on August 6, 1986. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Cryodyne Technologies, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1986
Date Received
February 27, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Liquid-Oxygen, Portable
Device Class
Class II
Regulation Number
868.5655
Review Panel
AN
Submission Type

Other clearances by Cryodyne Technologies, Inc.

  • K926464 — L.C.S.3000 (August 24, 1993)
  • K932520 — CALIBRATION GAS (August 19, 1993)
  • K881465 — CRYOBIOLOGICAL FREEZER (April 21, 1988)
  • K881467 — MICROSCOPE STAGE HEATER (April 18, 1988)
  • K881466 — CELL-CULTURE SHAKER (April 18, 1988)

Other clearances for product code BYJ

  • K130068 — DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) (July 19, 2013)
  • K113767 — MOUNTED MEDICAL OXYGEN SYSTEM (June 29, 2012)
  • K103324 — PRECISION LIQUID OXYGEN SYSTEM (April 21, 2011)
  • K101272 — MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 (August 20, 2010)
  • K081779 — GOLOX-93 (September 19, 2008)
  • K080023 — MODIFICATION TO: SPIRIT (June 16, 2008)
  • K072723 — RESPIRONICS GOLOX (March 20, 2008)
  • K072011 — COPD LIQUID OXYGEN PORTABLE, MODEL 300P (October 18, 2007)
  • K071581 — BACKPACK MEDICAL OXYGEN SYSTEM (July 11, 2007)
  • K050153 — SPIRIT, MODEL HAS (April 15, 2005)

FDA data resources