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FDA 510(k)

Sentinel Camera

K-Number: K243664 · 2024-12-17

ApplicantAi Optics
Decision Date2024-12-17
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Sentinel Camera is a medical device manufactured by Ai Optics. It received FDA 510(k) clearance on 2024-12-17 under approval number K243664. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sentinel Camera?

Sentinel Camera is a medical device that received FDA 510(k) clearance on 2024-12-17. It is manufactured by Ai Optics. The 510(k) number is K243664.

When was Sentinel Camera approved by the FDA?

Sentinel Camera received FDA 510(k) clearance on 2024-12-17, under approval number K243664.

What company makes Sentinel Camera?

Sentinel Camera is manufactured by Ai Optics.

What is the FDA product code for Sentinel Camera?

The FDA product code for Sentinel Camera is HKI.

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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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