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510(k) K122715

STELLAR 150 by Resmed Germany, Inc. — Product Code MNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2013
Date Received
September 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Resmed Germany, Inc.

  • K143272 — ApneaLink Air (April 30, 2015)
  • K131932 — APNEALINK PRO (November 8, 2013)
  • K113640 — STELLAR 150 (April 5, 2012)
  • K103167 — STELLAR 150 (March 1, 2011)
  • K083575 — APNEALINK PLUS, MODEL: 22328 (March 19, 2009)
  • K070263 — APNEALINK (June 15, 2007)
  • K061405 — APNEALINK, MODEL 22302 (July 25, 2006)

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  • K230173 — Servo-air Lite Ventilator System (July 6, 2023)
  • K213521 — Nihon Kohden NKV-330 Ventilator System (July 1, 2022)
  • K191624 — F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Versio (March 9, 2020)
  • K170367 — Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large (August 24, 2017)
  • K121623 — BIPAP A 40 VENTILATORY SUPPORT SYSTEM (December 14, 2012)
  • K113640 — STELLAR 150 (April 5, 2012)
  • K102985 — V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS (April 5, 2011)