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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 the device name listed in this FDA 510(k) record. The listed applicant is Chronisense Medical, Ltd.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) 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. The listed applicant is Chronisense Medical, Ltd.. The 510(k) number is K220351.

When did Polso Watch receive FDA 510(k) clearance?

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

Who is the listed applicant for Polso Watch?

The FDA 510(k) record lists Chronisense Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polso Watch?

The FDA product code for Polso Watch is DQA.

Related Devices (Code: DQA)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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