Prizma
K-Number: K173589 · 2018-11-30
ApplicantG-Medical Innovations , Ltd.
Decision Date2018-11-30
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Prizma is a medical device manufactured by G-Medical Innovations , Ltd.. It received FDA 510(k) clearance on 2018-11-30 under approval number K173589. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Prizma?
Prizma is a medical device that received FDA 510(k) clearance on 2018-11-30. It is manufactured by G-Medical Innovations , Ltd.. The 510(k) number is K173589.
When was Prizma approved by the FDA?
Prizma received FDA 510(k) clearance on 2018-11-30, under approval number K173589.
What company makes Prizma?
Prizma is manufactured by G-Medical Innovations , Ltd..
What is the FDA product code for Prizma?
The FDA product code for Prizma is DXH. This falls under the Hematology category.
Other Devices by G-Medical Innovations , Ltd.
Related Devices (Code: DXH)
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.