KardioScreen
K-Number: K191692 · 2020-01-10
ApplicantImedrix Inc. (Formerly Piitech Inc.)
Decision Date2020-01-10
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
KardioScreen is a medical device manufactured by Imedrix Inc. (Formerly Piitech Inc.). It received FDA 510(k) clearance on 2020-01-10 under approval number K191692. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the KardioScreen?
KardioScreen is a medical device that received FDA 510(k) clearance on 2020-01-10. It is manufactured by Imedrix Inc. (Formerly Piitech Inc.). The 510(k) number is K191692.
When was KardioScreen approved by the FDA?
KardioScreen received FDA 510(k) clearance on 2020-01-10, under approval number K191692.
What company makes KardioScreen?
KardioScreen is manufactured by Imedrix Inc. (Formerly Piitech Inc.).
What is the FDA product code for KardioScreen?
The FDA product code for KardioScreen is DPS.
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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.