MS-ONE, MODEL MS-1— 510(k) K003258

Substantially Equivalent

Home Wellness West

FDA 510(k) clearance K003258 for MS-ONE, MODEL MS-1, Substantially Equivalent on 2001-01-12. Applicant: Home Wellness West. Device class: 2.

Clearance details

Applicant: Home Wellness West
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2000-10-18
Decision date: 2001-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.