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FDA 510(k)

Tidepool Loop

K-Number: K203689 · 2023-01-23

ApplicantTidepool Project
Decision Date2023-01-23
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Tidepool Loop is a medical device manufactured by Tidepool Project. It received FDA 510(k) clearance on 2023-01-23 under approval number K203689. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tidepool Loop?

Tidepool Loop is a medical device that received FDA 510(k) clearance on 2023-01-23. It is manufactured by Tidepool Project. The 510(k) number is K203689.

When was Tidepool Loop approved by the FDA?

Tidepool Loop received FDA 510(k) clearance on 2023-01-23, under approval number K203689.

What company makes Tidepool Loop?

Tidepool Loop is manufactured by Tidepool Project.

What is the FDA product code for Tidepool Loop?

The FDA product code for Tidepool Loop is QJI.

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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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