Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Slow Wave DS8

K-Number: K191320 · 2020-10-02

ApplicantSlow Wave, Inc.
Decision Date2020-10-02
Product CodeLQZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Slow Wave DS8 is a medical device manufactured by Slow Wave, Inc.. It received FDA 510(k) clearance on 2020-10-02 under approval number K191320. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Slow Wave DS8?

Slow Wave DS8 is a medical device that received FDA 510(k) clearance on 2020-10-02. It is manufactured by Slow Wave, Inc.. The 510(k) number is K191320.

When was Slow Wave DS8 approved by the FDA?

Slow Wave DS8 received FDA 510(k) clearance on 2020-10-02, under approval number K191320.

What company makes Slow Wave DS8?

Slow Wave DS8 is manufactured by Slow Wave, Inc..

What is the FDA product code for Slow Wave DS8?

The FDA product code for Slow Wave DS8 is LQZ.

Other Devices by Slow Wave, Inc.

K240463Slow Wave DS8 (SWDS802)

Related Devices (Code: LQZ)

K162816SML-OSA2 AppliancesSelane Products, Inc. K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC K203712The SlideBiotex, Inc. K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC K233754AIO BreatheAiomega, LLC

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.

↑