Class Class II

Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask (K241830)

K241830 2024-10-18 Traditional
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Description

Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask by Sleepnet Corporation, an FDA 510(k) cleared anesthesiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241830
Clearance Date2024-10-18
Clearance TypeTraditional
Product CodeBZD
Regulation Number868.5905

Categories

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Predicate lineage for K241830

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask (K241830) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K120463MOJO, VERASEALSleepnet Corporation2012

Trace the full predicate network for K241830

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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