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510(k) K153387

Luna CPAP and Auto CPAP System by 3B Medical, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2016
Date Received
November 23, 2015
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.

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  • K200496 — Aer X (July 24, 2020)
  • K160127 — iCodeConnect (November 10, 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)

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