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510(k) K971545

PROTEGE LIQUID OXYGEN SYSTEM by Healthdyne Technologies, Inc. — Product Code BYJ

K971545 is an FDA 510(k) premarket notification submitted by Healthdyne Technologies, Inc. for the device "PROTEGE LIQUID OXYGEN SYSTEM". The FDA issued a decision of Substantially Equivalent on July 25, 1997. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Healthdyne Technologies, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1997
Date Received
April 28, 1997
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 Healthdyne Technologies, Inc.

  • K983572 — SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 (March 19, 1999)
  • K974453 — NASAL INTERFACE MODEL 7910 (August 4, 1998)
  • K974879 — MODEL 7410 VOYAGER (June 29, 1998)
  • K972614 — TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 6 (January 20, 1998)
  • K971867 — ALICE 4R SYSTEM (August 13, 1997)
  • K970173 — MODEL 1700 TRANQUILITY BILEVEL SYSTEM (April 16, 1997)
  • K962517 — MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV (February 20, 1997)
  • K943509 — 7300 NASAL CPAP SYSTEM (August 5, 1994)

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