Rapid ICH
K-Number: K193087 · 2020-03-31
ApplicantIschemaview Incorporated
Decision Date2020-03-31
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Rapid ICH is a medical device manufactured by Ischemaview Incorporated. It received FDA 510(k) clearance on 2020-03-31 under approval number K193087. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Rapid ICH?
Rapid ICH is a medical device that received FDA 510(k) clearance on 2020-03-31. It is manufactured by Ischemaview Incorporated. The 510(k) number is K193087.
When was Rapid ICH approved by the FDA?
Rapid ICH received FDA 510(k) clearance on 2020-03-31, under approval number K193087.
What company makes Rapid ICH?
Rapid ICH is manufactured by Ischemaview Incorporated.
What is the FDA product code for Rapid ICH?
The FDA product code for Rapid ICH is QAS.
Related Devices (Code: QAS)
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.