Slow Wave DS8— 510(k) K191320

Substantially Equivalent

Slow Wave, Inc.

FDA 510(k) clearance K191320 for Slow Wave DS8, Substantially Equivalent on 2020-10-02. Applicant: Slow Wave, Inc.. Device class: 2.

Clearance details

Applicant: Slow Wave, Inc.
Product code: Code LQZ
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2019-05-15
Decision date: 2020-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spicewood, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.