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510(k) K973004

KNIGHTSTAR 335 by Puritan Bennett Corp. — Product Code MNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1998
Date Received
August 13, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class
Class II
Regulation Number
868.5895
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)
  • K993220 — PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM (October 22, 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)

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  • K122715 — STELLAR 150 (June 17, 2013)
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  • K113640 — STELLAR 150 (April 5, 2012)