SubtleREFORMAT (1.x)
K-Number: K233699 · 2024-04-29
ApplicantSubtle Medical, Inc.
Decision Date2024-04-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SubtleREFORMAT (1.x) is a medical device manufactured by Subtle Medical, Inc.. It received FDA 510(k) clearance on 2024-04-29 under approval number K233699. 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 SubtleREFORMAT (1.x)?
SubtleREFORMAT (1.x) is a medical device that received FDA 510(k) clearance on 2024-04-29. It is manufactured by Subtle Medical, Inc.. The 510(k) number is K233699.
When was SubtleREFORMAT (1.x) approved by the FDA?
SubtleREFORMAT (1.x) received FDA 510(k) clearance on 2024-04-29, under approval number K233699.
What company makes SubtleREFORMAT (1.x)?
SubtleREFORMAT (1.x) is manufactured by Subtle Medical, Inc..
What is the FDA product code for SubtleREFORMAT (1.x)?
The FDA product code for SubtleREFORMAT (1.x) is LLZ.
Other Devices by Subtle Medical, Inc.
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.