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510(k) K240779

Vivo 3 by Breas Medical AB — Product Code MNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2024
Date Received
March 21, 2024
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 Breas Medical AB

  • K242485 — EveryWare (May 20, 2025)
  • K242438 — Clearo (May 16, 2025)
  • K233452 — Vivo 45 LS (January 13, 2025)
  • K240778 — Vivo 1, Vivo 2 (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 MNT

  • K242931 — HFT750U (May 15, 2025)
  • K233643 — F&P Airvo 3 NIV (PT311US) (August 9, 2024)
  • K230173 — Servo-air Lite Ventilator System (July 6, 2023)
  • K213521 — Nihon Kohden NKV-330 Ventilator System (July 1, 2022)
  • K191624 — F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Versio (March 9, 2020)
  • K170367 — Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large (August 24, 2017)
  • K122715 — STELLAR 150 (June 17, 2013)
  • K121623 — BIPAP A 40 VENTILATORY SUPPORT SYSTEM (December 14, 2012)
  • K113640 — STELLAR 150 (April 5, 2012)
  • K102985 — V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS (April 5, 2011)