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FDA 510(k)

ICS Dizcovery (1091)

K-Number: K242198 · 2025-02-14

ApplicantNatus Medical Denmark Aps
Decision Date2025-02-14
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ICS Dizcovery (1091) is a medical device manufactured by Natus Medical Denmark Aps. It received FDA 510(k) clearance on 2025-02-14 under approval number K242198. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICS Dizcovery (1091)?

ICS Dizcovery (1091) is a medical device that received FDA 510(k) clearance on 2025-02-14. It is manufactured by Natus Medical Denmark Aps. The 510(k) number is K242198.

When was ICS Dizcovery (1091) approved by the FDA?

ICS Dizcovery (1091) received FDA 510(k) clearance on 2025-02-14, under approval number K242198.

What company makes ICS Dizcovery (1091)?

ICS Dizcovery (1091) is manufactured by Natus Medical Denmark Aps.

What is the FDA product code for ICS Dizcovery (1091)?

The FDA product code for ICS Dizcovery (1091) is GWN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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