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FDA 510(k)

NightWatch+ US

K-Number: K243199 · 2025-07-12

ApplicantLivassured BV
Decision Date2025-07-12
Product CodePOS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NightWatch+ US is the device name listed in this FDA 510(k) record. The listed applicant is Livassured BV. It received FDA 510(k) clearance on 2025-07-12 under 510(k) number K243199. The device is classified under product code POS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NightWatch+ US?

NightWatch+ US is a medical device that received FDA 510(k) clearance on 2025-07-12. The listed applicant is Livassured BV. The 510(k) number is K243199.

When did NightWatch+ US receive FDA 510(k) clearance?

NightWatch+ US received FDA 510(k) clearance on 2025-07-12, under 510(k) number K243199.

Who is the listed applicant for NightWatch+ US?

The FDA 510(k) record lists Livassured BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NightWatch+ US?

The FDA product code for NightWatch+ US is POS.

Related Devices (Code: POS)

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.

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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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