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Sleepnet Corporation

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K251847 Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskBZD2026-01-15 View
510(k) K241830 Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented MaskBZD2024-10-18 View
510(k) K241943 Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented MaskCBK2024-08-28 View
510(k) K241661 Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskBZD2024-07-10 View
510(k) K241520 Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented MaskCBK2024-06-27 View
510(k) K241469 iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskBZD2024-06-15 View
510(k) K211274 iQ 2 Nasal Mask, Phantom 2 Nasal MaskBZD2022-01-10 View
510(k) K203601 Innova Nasal Non-Vented MaskBZD2021-04-30 View
510(k) K190533 Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-VentedCBK2019-07-26 View
510(k) K190254 Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskBZD2019-07-05 View
510(k) K121321 HARD SHELL VENTED NASAL MASKBZD2012-11-30 View
510(k) K121692 MINIME 2 NASAL MASKBZD2012-11-05 View
510(k) K120463 MOJO, VERASEALBZD2012-07-27 View
510(k) K102317 IQ VENTILATION NASAL MASKBZD2011-05-17 View
510(k) K090935 MINIME PEDIATRIC MASKBZD2009-07-01 View
510(k) K063806 SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTEDCBK2007-05-17 View
510(k) K060273 SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837BZD2006-05-02 View
510(k) K021534 IQ NASAL MASK, MODEL 50160 REV. DBZD2002-07-02 View
510(k) K013306 MINIME NASAL MASK, MODEL P/N 50220BZD2001-11-02 View
510(k) K993269 IQ NASAL MASK, MODEL P/N 50160BZD1999-10-27 View
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