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FDA 510(k)

Soberlink Cellular Device and Sober Sky Web Portal

K-Number: K160613 · 2016-07-14

ApplicantSoberlink Healthcare, LLC
Decision Date2016-07-14
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Soberlink Cellular Device and Sober Sky Web Portal is the device name listed in this FDA 510(k) record. The listed applicant is Soberlink Healthcare, LLC. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K160613. The device is classified under product code DJZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soberlink Cellular Device and Sober Sky Web Portal?

Soberlink Cellular Device and Sober Sky Web Portal is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Soberlink Healthcare, LLC. The 510(k) number is K160613.

When did Soberlink Cellular Device and Sober Sky Web Portal receive FDA 510(k) clearance?

Soberlink Cellular Device and Sober Sky Web Portal received FDA 510(k) clearance on 2016-07-14, under 510(k) number K160613.

Who is the listed applicant for Soberlink Cellular Device and Sober Sky Web Portal?

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

What is the FDA product code for Soberlink Cellular Device and Sober Sky Web Portal?

The FDA product code for Soberlink Cellular Device and Sober Sky Web Portal is DJZ.

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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