SubtlePET
K-Number: K211964 · 2021-09-28
ApplicantSubtle Medical, Inc.
Decision Date2021-09-28
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SubtlePET is a medical device manufactured by Subtle Medical, Inc.. It received FDA 510(k) clearance on 2021-09-28 under approval number K211964. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SubtlePET?
SubtlePET is a medical device that received FDA 510(k) clearance on 2021-09-28. It is manufactured by Subtle Medical, Inc.. The 510(k) number is K211964.
When was SubtlePET approved by the FDA?
SubtlePET received FDA 510(k) clearance on 2021-09-28, under approval number K211964.
What company makes SubtlePET?
SubtlePET is manufactured by Subtle Medical, Inc..
What is the FDA product code for SubtlePET?
The FDA product code for SubtlePET is KPS.
Other Devices by Subtle Medical, Inc.
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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.