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FDA 510(k)

Careverse CoronaryDoc (Careverse CoronaryDoc)

K-Number: K251656 · 2025-09-04

ApplicantCareverse Technology Pte. , Ltd.
Decision Date2025-09-04
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Careverse CoronaryDoc (Careverse CoronaryDoc) is a medical device manufactured by Careverse Technology Pte. , Ltd.. It received FDA 510(k) clearance on 2025-09-04 under approval number K251656. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Careverse CoronaryDoc (Careverse CoronaryDoc)?

Careverse CoronaryDoc (Careverse CoronaryDoc) is a medical device that received FDA 510(k) clearance on 2025-09-04. It is manufactured by Careverse Technology Pte. , Ltd.. The 510(k) number is K251656.

When was Careverse CoronaryDoc (Careverse CoronaryDoc) approved by the FDA?

Careverse CoronaryDoc (Careverse CoronaryDoc) received FDA 510(k) clearance on 2025-09-04, under approval number K251656.

What company makes Careverse CoronaryDoc (Careverse CoronaryDoc)?

Careverse CoronaryDoc (Careverse CoronaryDoc) is manufactured by Careverse Technology Pte. , Ltd..

What is the FDA product code for Careverse CoronaryDoc (Careverse CoronaryDoc)?

The FDA product code for Careverse CoronaryDoc (Careverse CoronaryDoc) is QIH.

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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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