SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM— 510(k) K060150

Substantially Equivalent

Andante Medical Devices , Ltd.

FDA 510(k) clearance K060150 for SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM, Substantially Equivalent on 2006-02-23. Applicant: Andante Medical Devices , Ltd..

Clearance details

Applicant: Andante Medical Devices , Ltd.
Product code: Code IRN
Advisory panel: Physical Medicine
Date received: 2006-01-20
Decision date: 2006-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Ramat Gan, IL

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