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3B Medical, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K212263 Luna G3 BPAP SystemBZD2022-03-25 View
510(k) K201620 Luna® G3 BPAP 25ABZD2021-01-29 View
510(k) K200496 Aer XCAW2020-07-24 View
510(k) K160127 iCodeConnectBZD2016-11-10 View
510(k) K153387 Luna CPAP and Auto CPAP SystemBZD2016-09-08 View
510(k) K131901 IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2BZD2013-12-23 View
510(k) K132967 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAPBZD2013-12-06 View
510(k) K131707 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMSBZD2013-08-22 View
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