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510(k) K853775

PENOX HIGH FLOW MANIFOLD by Penox Technologies, Inc. — Product Code BYJ

K853775 is an FDA 510(k) premarket notification submitted by Penox Technologies, Inc. for the device "PENOX HIGH FLOW MANIFOLD". The FDA issued a decision of Substantially Equivalent on November 29, 1985. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Penox Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1985
Date Received
September 10, 1985
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 Penox Technologies, Inc.

  • K864667 — PENOX HOSPITAL BED (January 21, 1987)
  • K863978 — PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) (December 15, 1986)
  • K862654 — MODIFIED PENOX LIFT CHAIR (July 18, 1986)
  • K852109 — PENOX PERFORMER WHEELCHAIR (August 22, 1985)
  • K851218 — PENOX LIFT CHAIR (June 21, 1985)
  • K851219 — FILL HOSE SAFETY ADAPTER (June 18, 1985)
  • K851216 — PENOX DUAL FEED MANIFOLD (June 18, 1985)
  • K851215 — T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER (June 18, 1985)
  • K851217 — PENOX DUAL FLOW MINIFOLD (June 18, 1985)

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