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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 the device name listed in this FDA 510(k) record. The listed applicant is Careverse Technology Pte. , Ltd.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) 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. The listed applicant is Careverse Technology Pte. , Ltd.. The 510(k) number is K251656.

When did Careverse CoronaryDoc (Careverse CoronaryDoc) receive FDA 510(k) clearance?

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

Who is the listed applicant for Careverse CoronaryDoc (Careverse CoronaryDoc)?

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

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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