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FDA 510(k)

Rapid ASPECTS

K-Number: K200760 · 2020-06-26

ApplicantIschemaview, Inc.
Decision Date2020-06-26
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid ASPECTS is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2020-06-26 under approval number K200760. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid ASPECTS?

Rapid ASPECTS is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by Ischemaview, Inc.. The 510(k) number is K200760.

When was Rapid ASPECTS approved by the FDA?

Rapid ASPECTS received FDA 510(k) clearance on 2020-06-26, under approval number K200760.

What company makes Rapid ASPECTS?

Rapid ASPECTS is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid ASPECTS?

The FDA product code for Rapid ASPECTS is POK.

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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.

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