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510(k) K171827

ReddyPort NIV Access Elbow by Smd Manufacturing, LLC — Product Code MNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2018
Date Received
June 20, 2017
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 Smd Manufacturing, LLC

  • K231064 — ReddyPort Elbow (July 13, 2023)

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)
  • 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)