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510(k) K200480

DreamStation 2 System, DreamStation 2 Advanced System by Respironics, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2020
Date Received
February 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Respironics, Inc.

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  • K210386 — Magneto Nasal Mask (July 12, 2021)
  • K202142 — Sleepware G3 (October 29, 2020)
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  • K183226 — Care Orchestrator Essence (October 18, 2019)
  • K183625 — SomnaPatch (October 18, 2019)
  • K181170 — Trilogy Evo Universal (July 18, 2019)
  • K181166 — Trilogy Evo (July 18, 2019)

Other clearances for product code BZD

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  • K253939 — DeltaWave Nasal Pillow System (January 7, 2026)
  • K251770 — SleepRes PAP System (December 15, 2025)
  • K251657 — Personalized Therapy Comfort Settings (PTCS) (December 5, 2025)
  • K243583 — F&P Nova Nasal Mask (June 18, 2025)
  • K250624 — myAir (May 28, 2025)
  • K243023 — WiZARD 520 Full Face Mask (May 23, 2025)
  • K242547 — AirFit F20 Mask System; AirFit F20 NM Mask System (May 19, 2025)
  • K242935 — Respiration Data Management Software (PAP Link PC) (January 15, 2025)
  • K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-0 (December 31, 2024)