SMART (SMART-D, SMART-DX)— 510(k) K131660

Substantially Equivalent

Bts S.P.A.

FDA 510(k) clearance K131660 for SMART (SMART-D, SMART-DX), Substantially Equivalent on 2014-04-17. Applicant: Bts S.P.A.. Device class: 2.

Clearance details

Applicant: Bts S.P.A.
Product code: Code LXJ
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 2013-06-06
Decision date: 2014-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Padova, IT

Download summary PDF View on FDA.gov ↗

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More clearances from Bts S.P.A.

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