SMARTSTEP SYSTEM— 510(k) K023161

Substantially Equivalent

Andante Medical Device, Ltd.

FDA 510(k) clearance K023161 for SMARTSTEP SYSTEM, Substantially Equivalent on 2002-12-10. Applicant: Andante Medical Device, Ltd.. Device class: 2.

Clearance details

Applicant: Andante Medical Device, Ltd.
Product code: Code IRN
Device class: Class 2
Regulation: 21 CFR 890.5575
Advisory panel: Physical Medicine
Date received: 2002-09-23
Decision date: 2002-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Ananna 43373, IL

Download summary PDF View on FDA.gov ↗

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