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FDA 510(k)

SPARK Scan

K-Number: K231457 · 2023-08-18

ApplicantSpark Neuro, Inc.
Decision Date2023-08-18
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPARK Scan is a medical device manufactured by Spark Neuro, Inc.. It received FDA 510(k) clearance on 2023-08-18 under approval number K231457. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPARK Scan?

SPARK Scan is a medical device that received FDA 510(k) clearance on 2023-08-18. It is manufactured by Spark Neuro, Inc.. The 510(k) number is K231457.

When was SPARK Scan approved by the FDA?

SPARK Scan received FDA 510(k) clearance on 2023-08-18, under approval number K231457.

What company makes SPARK Scan?

SPARK Scan is manufactured by Spark Neuro, Inc..

What is the FDA product code for SPARK Scan?

The FDA product code for SPARK Scan is GWQ.

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Official Source

View on FDA Database →

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