Delta III Pro
K-Number: K221903 · 2023-02-22
ApplicantDornier Medtech America, Inc.
Decision Date2023-02-22
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Delta III Pro is a medical device manufactured by Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2023-02-22 under approval number K221903. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Delta III Pro?
Delta III Pro is a medical device that received FDA 510(k) clearance on 2023-02-22. It is manufactured by Dornier Medtech America, Inc.. The 510(k) number is K221903.
When was Delta III Pro approved by the FDA?
Delta III Pro received FDA 510(k) clearance on 2023-02-22, under approval number K221903.
What company makes Delta III Pro?
Delta III Pro is manufactured by Dornier Medtech America, Inc..
What is the FDA product code for Delta III Pro?
The FDA product code for Delta III Pro is LNS.
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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.