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FDA 510(k)

SOLOHEALTH STATION

K-Number: K113402 · 2012-05-30

ApplicantSolohealth, Inc.
Decision Date2012-05-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOLOHEALTH STATION is the device name listed in this FDA 510(k) record. The listed applicant is Solohealth, Inc.. It received FDA 510(k) clearance on 2012-05-30 under 510(k) number K113402. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLOHEALTH STATION?

SOLOHEALTH STATION is a medical device that received FDA 510(k) clearance on 2012-05-30. The listed applicant is Solohealth, Inc.. The 510(k) number is K113402.

When did SOLOHEALTH STATION receive FDA 510(k) clearance?

SOLOHEALTH STATION received FDA 510(k) clearance on 2012-05-30, under 510(k) number K113402.

Who is the listed applicant for SOLOHEALTH STATION?

The FDA 510(k) record lists Solohealth, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLOHEALTH STATION?

The FDA product code for SOLOHEALTH STATION is DXN.

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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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