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510(k) K993220

PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM by Puritan Bennett Corp. — Product Code BYJ

K993220 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM". The FDA issued a decision of Substantially Equivalent on October 22, 1999. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1999
Date Received
September 27, 1999
Clearance Type
Special
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 Puritan Bennett Corp.

  • K063650 — VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 (February 15, 2007)
  • K053388 — MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION (April 4, 2006)
  • K023225 — PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE (December 18, 2002)
  • K022103 — PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM (September 27, 2002)
  • K001646 — PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION (October 20, 2000)
  • K002001 — BREEZE SLEEPGEAR WITH DREAMSEAL (September 6, 2000)
  • K993071 — PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OP (November 24, 1999)
  • K993088 — PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI (October 8, 1999)
  • K984535 — PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION (December 28, 1998)
  • K984379 — NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM (December 10, 1998)

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