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510(k) K161492

Juno VPAP ST-A by Resmed, Ltd. — Product Code MNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2017
Date Received
June 1, 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.

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  • 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)
  • 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)