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510(k) K212263

Luna G3 BPAP System by 3B Medical, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2022
Date Received
July 20, 2021
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 3B Medical, Inc.

  • K201620 — Luna® G3 BPAP 25A (January 29, 2021)
  • K200496 — Aer X (July 24, 2020)
  • K160127 — iCodeConnect (November 10, 2016)
  • K153387 — Luna CPAP and Auto CPAP System (September 8, 2016)
  • K141770 — LUNA CPAP AND AUTO-CPAP SYSTEM (April 22, 2015)
  • K133769 — 3B RESMART BPAP 25A, BMC RESMART BPAP 25A (August 25, 2014)
  • K131901 — IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 (December 23, 2013)
  • K132967 — 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP (December 6, 2013)
  • K131707 — 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS (August 22, 2013)

Other clearances for product code BZD

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  • 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)