SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM— 510(k) K121059

Name: FDA 510(k) clearance K121059
Creator: U.S. Food and Drug Administration
Published: 2012-08-07

Substantially Equivalent

Zimmer Medizinsystems GmbH

FDA 510(k) clearance K121059 for SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM, Substantially Equivalent on 2012-08-07. Applicant: Zimmer Medizinsystems GmbH. Device class: 2.

Clearance details

Applicant: Zimmer Medizinsystems GmbH
Product code: Code IMG
Device class: Class 2
Regulation: 21 CFR 890.5860
Advisory panel: Physical Medicine
Date received: 2012-04-06
Decision date: 2012-08-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Neu-Elm, DE

Download summary PDF View on FDA.gov ↗

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