FDA 510(k)

Claritas iPET

K-Number: K213140 · 2021-12-22

Decision Date2021-12-22

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Claritas iPET 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 2021-12-22 under 510(k) number K213140. 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 Claritas iPET?

Claritas iPET is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Claritas Healthtech Pte, Ltd.. The 510(k) number is K213140.

When did Claritas iPET receive FDA 510(k) clearance?

Claritas iPET received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213140.

Who is the listed applicant for Claritas iPET?

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 Claritas iPET?

The FDA product code for Claritas iPET 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.

K244016iPETcertum (v1.0)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.