Claritas iPET
K-Number: K213140 · 2021-12-22
ApplicantClaritas Healthtech Pte, Ltd.
Decision Date2021-12-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Claritas iPET is a medical device manufactured by Claritas Healthtech Pte, Ltd.. It received FDA 510(k) clearance on 2021-12-22 under approval 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. It is manufactured by Claritas Healthtech Pte, Ltd.. The 510(k) number is K213140.
When was Claritas iPET approved by the FDA?
Claritas iPET received FDA 510(k) clearance on 2021-12-22, under approval number K213140.
What company makes Claritas iPET?
Claritas iPET is manufactured by Claritas Healthtech Pte, Ltd..
What is the FDA product code for Claritas iPET?
The FDA product code for Claritas iPET is LLZ.
Other Devices by Claritas Healthtech Pte, Ltd.
Related Devices (Code: LLZ)
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.