Home / 510(k) Clearances / K111378

510(k) K111378

OXIMETRY INTERFACE KIT by Philips Respironics, Inc. — Product Code MNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2011
Date Received
May 17, 2011
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 Philips Respironics, Inc.

  • K233555 — AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask (July 31, 2024)

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)
  • 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)