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..

Clearance details

Applicant: Andante Medical Device, Ltd.
Product code: Code IRN
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 ↗

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