Medical Device Manufacturer · US , Manchester , NH

Sleepnet Corporation

23 submissions · 23 cleared · Since 1996
23
Total
23
Cleared
0
Denied

Sleepnet Corporation — FDA 510(k) Submissions

Sleepnet Corporation has submitted 23 FDA 510(k) premarket notifications since 1996, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ventilator, Non-continuous (respirator), Ventilator, Continuous, Facility Use, Humidifier, Respiratory Gas, (direct Patient Interface) . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
K251847 · BZD Ventilator,... · Anesthesiology
Jan 2026 213d
Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
K241830 · BZD Ventilator,... · Anesthesiology
Oct 2024 116d
Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
K241943 · CBK Ventilator, Continuous,... · Anesthesiology
Aug 2024 57d
Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask
K241661 · BZD Ventilator,... · Anesthesiology
Jul 2024 30d
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 Mask
K241520 · CBK Ventilator, Continuous,... · Anesthesiology
Jun 2024 29d
iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
K241469 · BZD Ventilator,... · Anesthesiology
Jun 2024 22d
iQ 2 Nasal Mask, Phantom 2 Nasal Mask
K211274 · BZD Ventilator,... · Anesthesiology
Jan 2022 258d
Innova Nasal Non-Vented Mask
K203601 · BZD Ventilator,... · Anesthesiology
Apr 2021 142d
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-Vented
K190533 · CBK Ventilator, Continuous,... · Anesthesiology
Jul 2019 144d
Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
K190254 · BZD Ventilator,... · Anesthesiology
Jul 2019 148d
HARD SHELL VENTED NASAL MASK
K121321 · BZD Ventilator,... · Anesthesiology
Nov 2012 212d
MINIME 2 NASAL MASK
K121692 · BZD Ventilator,... · Anesthesiology
Nov 2012 151d
MOJO, VERASEAL
K120463 · BZD Ventilator,... · Anesthesiology
Jul 2012 163d
IQ VENTILATION NASAL MASK
K102317 · BZD Ventilator,... · Anesthesiology
May 2011 274d
MINIME PEDIATRIC MASK
K090935 · BZD Ventilator,... · Anesthesiology
Jul 2009 90d
SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED
K063806 · CBK Ventilator, Continuous,... · Anesthesiology
May 2007 146d
SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837
K060273 · BZD Ventilator,... · Anesthesiology
May 2006 89d
IQ NASAL MASK, MODEL 50160 REV. D
K021534 · BZD Ventilator,... · Anesthesiology
Jul 2002 53d
MINIME NASAL MASK, MODEL P/N 50220
K013306 · BZD Ventilator,... · Anesthesiology
Nov 2001 29d
IQ NASAL MASK, MODEL P/N 50160
K993269 · BZD Ventilator,... · Anesthesiology
Oct 1999 27d
SLEEPNET HUMIDIFIER,(84200 PACKAGED)
K963025 · BTT Humidifier, Respiratory... · Anesthesiology
Nov 1996 88d
DPAP STEALTH SLEEPNET MODEL NUMBER 84000
K962713 · BZD Ventilator,... · Anesthesiology
Oct 1996 103d
THE IMS DPAP MASK, IMS MODEL NUMBER 82000
K953697 · BZD Ventilator,... · Anesthesiology
Jun 1996 310d
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