SubtleMR (2.3.x)
K-Number: K223623 · 2023-05-11
ApplicantSubtle Medical, Inc.
Decision Date2023-05-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SubtleMR (2.3.x) is a medical device manufactured by Subtle Medical, Inc.. It received FDA 510(k) clearance on 2023-05-11 under approval number K223623. 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 SubtleMR (2.3.x)?
SubtleMR (2.3.x) is a medical device that received FDA 510(k) clearance on 2023-05-11. It is manufactured by Subtle Medical, Inc.. The 510(k) number is K223623.
When was SubtleMR (2.3.x) approved by the FDA?
SubtleMR (2.3.x) received FDA 510(k) clearance on 2023-05-11, under approval number K223623.
What company makes SubtleMR (2.3.x)?
SubtleMR (2.3.x) is manufactured by Subtle Medical, Inc..
What is the FDA product code for SubtleMR (2.3.x)?
The FDA product code for SubtleMR (2.3.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.