FDA 510(k)

iPETcertum (v1.0)

K-Number: K244016 · 2025-08-05

Decision Date2025-08-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

iPETcertum (v1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Claritas Healthtech Pte, Ltd.. It received FDA 510(k) clearance on 2025-08-05 under 510(k) 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. The listed applicant is Claritas Healthtech Pte, Ltd.. The 510(k) number is K244016.

When did iPETcertum (v1.0) receive FDA 510(k) clearance?

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

Who is the listed applicant for iPETcertum (v1.0)?

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

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

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

Other records listing Claritas Healthtech Pte, Ltd. as applicant

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.

K213140Claritas iPET K212470iRAD

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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.