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FDA 510(k)

Avidhrt Sense SpO2

K-Number: K241086 · 2025-05-09

ApplicantAvidhrt, Inc.
Decision Date2025-05-09
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Avidhrt Sense SpO2 is a medical device manufactured by Avidhrt, Inc.. It received FDA 510(k) clearance on 2025-05-09 under approval number K241086. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avidhrt Sense SpO2?

Avidhrt Sense SpO2 is a medical device that received FDA 510(k) clearance on 2025-05-09. It is manufactured by Avidhrt, Inc.. The 510(k) number is K241086.

When was Avidhrt Sense SpO2 approved by the FDA?

Avidhrt Sense SpO2 received FDA 510(k) clearance on 2025-05-09, under approval number K241086.

What company makes Avidhrt Sense SpO2?

Avidhrt Sense SpO2 is manufactured by Avidhrt, Inc..

What is the FDA product code for Avidhrt Sense SpO2?

The FDA product code for Avidhrt Sense SpO2 is DQA.

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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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