SubtleHD (1.x)
K-Number: K243250 · 2025-02-12
ApplicantSubtle Medical, Inc.
Decision Date2025-02-12
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SubtleHD (1.x) is a medical device manufactured by Subtle Medical, Inc.. It received FDA 510(k) clearance on 2025-02-12 under approval number K243250. 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 SubtleHD (1.x)?
SubtleHD (1.x) is a medical device that received FDA 510(k) clearance on 2025-02-12. It is manufactured by Subtle Medical, Inc.. The 510(k) number is K243250.
When was SubtleHD (1.x) approved by the FDA?
SubtleHD (1.x) received FDA 510(k) clearance on 2025-02-12, under approval number K243250.
What company makes SubtleHD (1.x)?
SubtleHD (1.x) is manufactured by Subtle Medical, Inc..
What is the FDA product code for SubtleHD (1.x)?
The FDA product code for SubtleHD (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.