SubtleMR
K-Number: K203182 · 2021-02-26
ApplicantSubtle Medical, Inc.
Decision Date2021-02-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SubtleMR is a medical device manufactured by Subtle Medical, Inc.. It received FDA 510(k) clearance on 2021-02-26 under approval number K203182. 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?
SubtleMR is a medical device that received FDA 510(k) clearance on 2021-02-26. It is manufactured by Subtle Medical, Inc.. The 510(k) number is K203182.
When was SubtleMR approved by the FDA?
SubtleMR received FDA 510(k) clearance on 2021-02-26, under approval number K203182.
What company makes SubtleMR?
SubtleMR is manufactured by Subtle Medical, Inc..
What is the FDA product code for SubtleMR?
The FDA product code for SubtleMR 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.