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510(k) K213169

BPAP System by BMC Medical Co., Ltd. — Product Code MNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2022
Date Received
September 28, 2021
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 BMC Medical Co., Ltd.

  • K242935 — Respiration Data Management Software (PAP Link PC) (January 15, 2025)
  • K211155 — Auto CPAP System (March 9, 2022)
  • K133009 — NASAL MASK, NASAL MASK, FULL FACE MASK (April 23, 2014)

Other clearances for product code MNS

  • K251661 — Mariana Minerva; Mariana Nimbus (February 23, 2026)
  • K240778 — Vivo 1, Vivo 2 (December 13, 2024)
  • K231064 — ReddyPort Elbow (July 13, 2023)
  • 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)