SubtleSYNTH (1.x)
K-Number: K241329 · 2024-07-11
ApplicantSubtle Medical, Inc.
Decision Date2024-07-11
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SubtleSYNTH (1.x) is a medical device manufactured by Subtle Medical, Inc.. It received FDA 510(k) clearance on 2024-07-11 under approval number K241329. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SubtleSYNTH (1.x)?
SubtleSYNTH (1.x) is a medical device that received FDA 510(k) clearance on 2024-07-11. It is manufactured by Subtle Medical, Inc.. The 510(k) number is K241329.
When was SubtleSYNTH (1.x) approved by the FDA?
SubtleSYNTH (1.x) received FDA 510(k) clearance on 2024-07-11, under approval number K241329.
What company makes SubtleSYNTH (1.x)?
SubtleSYNTH (1.x) is manufactured by Subtle Medical, Inc..
What is the FDA product code for SubtleSYNTH (1.x)?
The FDA product code for SubtleSYNTH (1.x) is QIH.
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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.