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FDA 510(k)

NightOwl

K-Number: K213463 · 2021-12-16

ApplicantEctosense NV
Decision Date2021-12-16
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NightOwl is a medical device manufactured by Ectosense NV. It received FDA 510(k) clearance on 2021-12-16 under approval number K213463. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NightOwl?

NightOwl is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Ectosense NV. The 510(k) number is K213463.

When was NightOwl approved by the FDA?

NightOwl received FDA 510(k) clearance on 2021-12-16, under approval number K213463.

What company makes NightOwl?

NightOwl is manufactured by Ectosense NV.

What is the FDA product code for NightOwl?

The FDA product code for NightOwl is MNR.

Other Devices by Ectosense NV

K191031NightOwl K220028NightOwl

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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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