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FDA 510(k)

SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM

K-Number: K121059 · 2012-08-07

ApplicantZimmer Medizinsystems GmbH
Decision Date2012-08-07
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Medizinsystems GmbH. It received FDA 510(k) clearance on 2012-08-07 under 510(k) number K121059. The device is classified under product code IMG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM?

SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM is a medical device that received FDA 510(k) clearance on 2012-08-07. The listed applicant is Zimmer Medizinsystems GmbH. The 510(k) number is K121059.

When did SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM receive FDA 510(k) clearance?

SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM received FDA 510(k) clearance on 2012-08-07, under 510(k) number K121059.

Who is the listed applicant for SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM?

The FDA 510(k) record lists Zimmer Medizinsystems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM?

The FDA product code for SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM is IMG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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