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510(k) K934804

PURITAN-BENNETT COMPANION 320 I/E by Puritan Bennett Corp. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1995
Date Received
October 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
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 BZD

  • K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (January 15, 2026)
  • K253939 — DeltaWave Nasal Pillow System (January 7, 2026)
  • K251770 — SleepRes PAP System (December 15, 2025)
  • K251657 — Personalized Therapy Comfort Settings (PTCS) (December 5, 2025)
  • K243583 — F&P Nova Nasal Mask (June 18, 2025)
  • K250624 — myAir (May 28, 2025)
  • K243023 — WiZARD 520 Full Face Mask (May 23, 2025)
  • K242547 — AirFit F20 Mask System; AirFit F20 NM Mask System (May 19, 2025)
  • K242935 — Respiration Data Management Software (PAP Link PC) (January 15, 2025)
  • K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-0 (December 31, 2024)