Delta III Lithotripter
K-Number: K170122 · 2017-06-28
ApplicantDornier Medtech America
Decision Date2017-06-28
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Delta III Lithotripter is a medical device manufactured by Dornier Medtech America. It received FDA 510(k) clearance on 2017-06-28 under approval number K170122. 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 Lithotripter?
Delta III Lithotripter is a medical device that received FDA 510(k) clearance on 2017-06-28. It is manufactured by Dornier Medtech America. The 510(k) number is K170122.
When was Delta III Lithotripter approved by the FDA?
Delta III Lithotripter received FDA 510(k) clearance on 2017-06-28, under approval number K170122.
What company makes Delta III Lithotripter?
Delta III Lithotripter is manufactured by Dornier Medtech America.
What is the FDA product code for Delta III Lithotripter?
The FDA product code for Delta III Lithotripter is LNS.
Other Devices by Dornier Medtech America
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K221903Delta III ProDornier Medtech America, Inc.
K213772LM-9300 Plus LithotripterLite-Med, Inc.
K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.
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.