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FDA 510(k)

Polso Watch

K-Number: K220351 · 2022-11-18

ApplicantChronisense Medical, Ltd.
Decision Date2022-11-18
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Polso Watch is a medical device manufactured by Chronisense Medical, Ltd.. It received FDA 510(k) clearance on 2022-11-18 under approval number K220351. 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 Polso Watch?

Polso Watch is a medical device that received FDA 510(k) clearance on 2022-11-18. It is manufactured by Chronisense Medical, Ltd.. The 510(k) number is K220351.

When was Polso Watch approved by the FDA?

Polso Watch received FDA 510(k) clearance on 2022-11-18, under approval number K220351.

What company makes Polso Watch?

Polso Watch is manufactured by Chronisense Medical, Ltd..

What is the FDA product code for Polso Watch?

The FDA product code for Polso Watch 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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