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510(k) K240778

Vivo 1, Vivo 2 by Breas Medical AB — Product Code MNS

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, Non-Life-Supporting
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)
  • 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 MNS

  • K251661 — Mariana Minerva; Mariana Nimbus (February 23, 2026)
  • K231064 — ReddyPort Elbow (July 13, 2023)
  • K213169 — BPAP System (December 5, 2022)
  • K171827 — ReddyPort NIV Access Elbow (January 19, 2018)
  • K161492 — Juno VPAP ST-A (January 19, 2017)
  • K161487 — VPAP Adapt SV, VPAP Tx, S9 VPAP Tx (September 9, 2016)
  • K153061 — Juno VPAP ST-A (April 13, 2016)
  • K132371 — EASYCARE ONLINE (November 22, 2013)
  • K123511 — S9 VPAP TX (March 21, 2013)
  • K123557 — EASYCARE ONLINE (March 14, 2013)