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FDA 510(k)

Rapid SDH

K-Number: K232436 · 2023-10-25

ApplicantIschemaview, Inc.
Decision Date2023-10-25
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid SDH is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2023-10-25 under approval number K232436. 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 SDH?

Rapid SDH is a medical device that received FDA 510(k) clearance on 2023-10-25. It is manufactured by Ischemaview, Inc.. The 510(k) number is K232436.

When was Rapid SDH approved by the FDA?

Rapid SDH received FDA 510(k) clearance on 2023-10-25, under approval number K232436.

What company makes Rapid SDH?

Rapid SDH is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid SDH?

The FDA product code for Rapid SDH is QAS.

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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