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510(k) K161487

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx by Resmed, Ltd. — Product Code MNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2016
Date Received
May 31, 2016
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 Resmed, Ltd.

  • K251657 — Personalized Therapy Comfort Settings (PTCS) (December 5, 2025)
  • K250624 — myAir (May 28, 2025)
  • K241939 — EasyCare Tx 2 (September 27, 2024)
  • K241216 — myAir (September 26, 2024)
  • K200565 — Galapogos (January 17, 2021)
  • K183512 — Moore Park Mask (May 7, 2019)
  • K180497 — Scone Mask (June 15, 2018)
  • K172875 — Astral 100/150 (April 26, 2018)
  • K170924 — AirFit F20 (January 3, 2018)
  • K171212 — AirFit N20 (September 28, 2017)

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)
  • K213169 — BPAP System (December 5, 2022)
  • K171827 — ReddyPort NIV Access Elbow (January 19, 2018)
  • K161492 — Juno VPAP ST-A (January 19, 2017)
  • 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)