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510(k) K090113

BREAS VIVO 40 SYSTEM by Breas Medical AB — Product Code MNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2009
Date Received
January 21, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sv70 Ventilator
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Breas Medical AB

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  • K233452 — Vivo 45 LS (January 13, 2025)
  • K240779 — Vivo 3 (December 13, 2024)
  • K240778 — Vivo 1, Vivo 2 (December 13, 2024)
  • K193586 — Vivo 45 LS (January 27, 2021)
  • K160481 — Vivo 60 (November 9, 2016)
  • 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

  • K252182 — SV70 Ventilator (SV70) (April 6, 2026)
  • K242931 — HFT750U (May 15, 2025)
  • K240779 — Vivo 3 (December 13, 2024)
  • 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)