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510(k) K963633

VENTNET; CENTRAL MONITORING STATION by Puritan Bennett Corp. — Product Code MOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1996
Date Received
September 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory To Continuous Ventilator (Respirator)
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)

Other clearances for product code MOD

  • K242485 — EveryWare (May 20, 2025)
  • K161411 — Care Cycle Connect Application (February 17, 2017)
  • K091461 — BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE (August 14, 2009)
  • K052751 — VENTLINK SYSTEM (December 23, 2005)
  • K052244 — IISIS, VERSION 1.0 (October 13, 2005)
  • K040712 — AIR SAFETY HEPA, MODEL 3500 (June 3, 2004)
  • K022062 — IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 (May 6, 2003)
  • K010401 — TRI-PLEX ADAPTER (October 30, 2002)
  • K011861 — BERNOULLI VENTILATOR MANAGEMENT SYSTEM (November 6, 2001)
  • K935788 — BICORE SMARTCATH INTRATRACHEAL CATHETER (July 3, 1995)