Delta 3300
K-Number: K190437 · 2019-08-28
ApplicantNetech Corporation
Decision Date2019-08-28
Product CodeDRL
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Delta 3300 is a medical device manufactured by Netech Corporation. It received FDA 510(k) clearance on 2019-08-28 under approval number K190437. The device is classified under product code DRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Delta 3300?
Delta 3300 is a medical device that received FDA 510(k) clearance on 2019-08-28. It is manufactured by Netech Corporation. The 510(k) number is K190437.
When was Delta 3300 approved by the FDA?
Delta 3300 received FDA 510(k) clearance on 2019-08-28, under approval number K190437.
What company makes Delta 3300?
Delta 3300 is manufactured by Netech Corporation.
What is the FDA product code for Delta 3300?
The FDA product code for Delta 3300 is DRL.
Related Devices (Code: DRL)
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.