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510(k) K141770

LUNA CPAP AND AUTO-CPAP SYSTEM by 3B Medical, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2015
Date Received
July 1, 2014
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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  • K153387 — Luna CPAP and Auto CPAP System (September 8, 2016)
  • 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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