Triangle System
K-Number: K183319 · 2019-05-10
ApplicantAliveCor, Inc.
Decision Date2019-05-10
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Triangle System is a medical device manufactured by AliveCor, Inc.. It received FDA 510(k) clearance on 2019-05-10 under approval number K183319. 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 Triangle System?
Triangle System is a medical device that received FDA 510(k) clearance on 2019-05-10. It is manufactured by AliveCor, Inc.. The 510(k) number is K183319.
When was Triangle System approved by the FDA?
Triangle System received FDA 510(k) clearance on 2019-05-10, under approval number K183319.
What company makes Triangle System?
Triangle System is manufactured by AliveCor, Inc..
What is the FDA product code for Triangle System?
The FDA product code for Triangle System is DXH. This falls under the Hematology category.
Other Devices by AliveCor, Inc.
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.