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510(k) K233452

Vivo 45 LS by Breas Medical AB — Product Code NOU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2025
Date Received
October 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Continuous, Ventilator, Home Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.

Other clearances by Breas Medical AB

  • K242485 — EveryWare (May 20, 2025)
  • K242438 — Clearo (May 16, 2025)
  • K240778 — Vivo 1, Vivo 2 (December 13, 2024)
  • K240779 — Vivo 3 (December 13, 2024)
  • K193586 — Vivo 45 LS (January 27, 2021)
  • K160481 — Vivo 60 (November 9, 2016)
  • K090113 — BREAS VIVO 40 SYSTEM (May 14, 2009)
  • K071702 — BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 (February 15, 2008)
  • K063476 — BREAS ISLEEP 20I (January 22, 2007)
  • K060657 — ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. (August 18, 2006)

Other clearances for product code NOU

  • K193586 — Vivo 45 LS (January 27, 2021)
  • K160481 — Vivo 60 (November 9, 2016)
  • K123144 — VIVO 50 (June 18, 2013)
  • K034032 — PLV CONTINUUM VENTILATOR, MODEL P2000 (March 16, 2004)
  • K022750 — PLV CONTINUUM VENTILATOR, MODEL P1000 (November 20, 2003)
  • K021981 — IVENT 201 PORTABLE VENTILATOR (August 13, 2003)