deepLive (OSP12 + DMS)
K-Number: K252851 · 2025-10-07
ApplicantDamae Medical
Decision Date2025-10-07
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
deepLive (OSP12 + DMS) is a medical device manufactured by Damae Medical. It received FDA 510(k) clearance on 2025-10-07 under approval number K252851. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the deepLive (OSP12 + DMS)?
deepLive (OSP12 + DMS) is a medical device that received FDA 510(k) clearance on 2025-10-07. It is manufactured by Damae Medical. The 510(k) number is K252851.
When was deepLive (OSP12 + DMS) approved by the FDA?
deepLive (OSP12 + DMS) received FDA 510(k) clearance on 2025-10-07, under approval number K252851.
What company makes deepLive (OSP12 + DMS)?
deepLive (OSP12 + DMS) is manufactured by Damae Medical.
What is the FDA product code for deepLive (OSP12 + DMS)?
The FDA product code for deepLive (OSP12 + DMS) is NQQ.
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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.