NightOwl
K-Number: K220028 · 2022-02-24
Device Summary
Frequently Asked Questions
What is the NightOwl?
NightOwl is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is Ectosense NV. The 510(k) number is K220028.
When did NightOwl receive FDA 510(k) clearance?
NightOwl received FDA 510(k) clearance on 2022-02-24, under 510(k) number K220028.
Who is the listed applicant for NightOwl?
The FDA 510(k) record lists Ectosense NV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NightOwl?
The FDA product code for NightOwl is MNR.
Other records listing Ectosense NV as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: MNR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.