CardIQ Flow
K-Number: K192277 · 2020-02-14
ApplicantGE Medical Systems SCS
Decision Date2020-02-14
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CardIQ Flow is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2020-02-14 under approval number K192277. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CardIQ Flow?
CardIQ Flow is a medical device that received FDA 510(k) clearance on 2020-02-14. It is manufactured by GE Medical Systems SCS. The 510(k) number is K192277.
When was CardIQ Flow approved by the FDA?
CardIQ Flow received FDA 510(k) clearance on 2020-02-14, under approval number K192277.
What company makes CardIQ Flow?
CardIQ Flow is manufactured by GE Medical Systems SCS.
What is the FDA product code for CardIQ Flow?
The FDA product code for CardIQ Flow is KPS.
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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.