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FDA 510(k)

Slow Wave DS8 (SWDS802)

K-Number: K240463 · 2024-06-04

ApplicantSlow Wave, Inc.
Decision Date2024-06-04
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Slow Wave DS8 (SWDS802) is a medical device manufactured by Slow Wave, Inc.. It received FDA 510(k) clearance on 2024-06-04 under approval number K240463. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Slow Wave DS8 (SWDS802)?

Slow Wave DS8 (SWDS802) is a medical device that received FDA 510(k) clearance on 2024-06-04. It is manufactured by Slow Wave, Inc.. The 510(k) number is K240463.

When was Slow Wave DS8 (SWDS802) approved by the FDA?

Slow Wave DS8 (SWDS802) received FDA 510(k) clearance on 2024-06-04, under approval number K240463.

What company makes Slow Wave DS8 (SWDS802)?

Slow Wave DS8 (SWDS802) is manufactured by Slow Wave, Inc..

What is the FDA product code for Slow Wave DS8 (SWDS802)?

The FDA product code for Slow Wave DS8 (SWDS802) is MQC.

Other Devices by Slow Wave, Inc.

K191320Slow Wave DS8

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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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