DeltaScan Monitor
K-Number: K222680 · 2023-02-02
ApplicantProlira B.V.
Decision Date2023-02-02
Product CodeNCG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
DeltaScan Monitor is a medical device manufactured by Prolira B.V.. It received FDA 510(k) clearance on 2023-02-02 under approval number K222680. The device is classified under product code NCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DeltaScan Monitor?
DeltaScan Monitor is a medical device that received FDA 510(k) clearance on 2023-02-02. It is manufactured by Prolira B.V.. The 510(k) number is K222680.
When was DeltaScan Monitor approved by the FDA?
DeltaScan Monitor received FDA 510(k) clearance on 2023-02-02, under approval number K222680.
What company makes DeltaScan Monitor?
DeltaScan Monitor is manufactured by Prolira B.V..
What is the FDA product code for DeltaScan Monitor?
The FDA product code for DeltaScan Monitor is NCG.
Other Devices by Prolira B.V.
Related Devices (Code: NCG)
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.