Katalyst Mark 1 Muscle Stimulation System Model 2— 510(k) K181199

Name: FDA 510(k) clearance K181199
Creator: U.S. Food and Drug Administration
Published: 2018-09-20

Substantially Equivalent

Katalyst, Inc.

FDA 510(k) clearance K181199 for Katalyst Mark 1 Muscle Stimulation System Model 2, Substantially Equivalent on 2018-09-20. Applicant: Katalyst, Inc.. Device class: 2.

Clearance details

Applicant: Katalyst, Inc.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2018-05-07
Decision date: 2018-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, 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.