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FDA 510(k)

Rapid (6.0)

K-Number: K233512 · 2024-01-16

ApplicantIschemaview, Inc.
Decision Date2024-01-16
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid (6.0) is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2024-01-16 under approval number K233512. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid (6.0)?

Rapid (6.0) is a medical device that received FDA 510(k) clearance on 2024-01-16. It is manufactured by Ischemaview, Inc.. The 510(k) number is K233512.

When was Rapid (6.0) approved by the FDA?

Rapid (6.0) received FDA 510(k) clearance on 2024-01-16, under approval number K233512.

What company makes Rapid (6.0)?

Rapid (6.0) is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid (6.0)?

The FDA product code for Rapid (6.0) is QIH.

Other Devices by Ischemaview, Inc.

K182130iSchemaView RAPID K172477iSchemaView RAPID K200941Rapid LVO K200760Rapid ASPECTS K221456Rapid ICH K221248Rapid LVO

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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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