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510(k) K993220

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

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

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  • 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

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  • 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)