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FDA 510(k)

iPETcertum (v1.0)

K-Number: K244016 · 2025-08-05

ApplicantClaritas Healthtech Pte, Ltd.
Decision Date2025-08-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iPETcertum (v1.0) is a medical device manufactured by Claritas Healthtech Pte, Ltd.. It received FDA 510(k) clearance on 2025-08-05 under approval number K244016. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iPETcertum (v1.0)?

iPETcertum (v1.0) is a medical device that received FDA 510(k) clearance on 2025-08-05. It is manufactured by Claritas Healthtech Pte, Ltd.. The 510(k) number is K244016.

When was iPETcertum (v1.0) approved by the FDA?

iPETcertum (v1.0) received FDA 510(k) clearance on 2025-08-05, under approval number K244016.

What company makes iPETcertum (v1.0)?

iPETcertum (v1.0) is manufactured by Claritas Healthtech Pte, Ltd..

What is the FDA product code for iPETcertum (v1.0)?

The FDA product code for iPETcertum (v1.0) is LLZ.

Other Devices by Claritas Healthtech Pte, Ltd.

K213140Claritas iPET K212470iRAD

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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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