Cleerly ISCHEMIA
K-Number: K231335 · 2023-09-08
ApplicantCleerly, Inc.
Decision Date2023-09-08
Product CodeQXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Cleerly ISCHEMIA is a medical device manufactured by Cleerly, Inc.. It received FDA 510(k) clearance on 2023-09-08 under approval number K231335. The device is classified under product code QXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cleerly ISCHEMIA?
Cleerly ISCHEMIA is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Cleerly, Inc.. The 510(k) number is K231335.
When was Cleerly ISCHEMIA approved by the FDA?
Cleerly ISCHEMIA received FDA 510(k) clearance on 2023-09-08, under approval number K231335.
What company makes Cleerly ISCHEMIA?
Cleerly ISCHEMIA is manufactured by Cleerly, Inc..
What is the FDA product code for Cleerly ISCHEMIA?
The FDA product code for Cleerly ISCHEMIA is QXZ.
Other Devices by Cleerly, Inc.
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.