Class Class II

ICS Dizcovery (1091) (K242198)

K242198 2025-02-14 Traditional
Home/ Devices/ ICS Dizcovery (1091) (K242198)

Description

ICS Dizcovery (1091) by Natus Medical Denmark Aps, an FDA 510(k) cleared neurology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242198
Clearance Date2025-02-14
Clearance TypeTraditional
Product CodeGWN
Regulation Number882.1460

Categories

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Predicate lineage for K242198

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. ICS Dizcovery (1091) (K242198) 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
K151504ICS ImpulseGn Otometrics2015

Trace the full predicate network for K242198

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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