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 a medical device manufactured by Soberlink Healthcare, LLC. It received FDA 510(k) clearance on 2016-07-14 under approval 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. It is manufactured by Soberlink Healthcare, LLC. The 510(k) number is K160613.
When was Soberlink Cellular Device and Sober Sky Web Portal approved by the FDA?
Soberlink Cellular Device and Sober Sky Web Portal received FDA 510(k) clearance on 2016-07-14, under approval number K160613.
What company makes Soberlink Cellular Device and Sober Sky Web Portal?
Soberlink Cellular Device and Sober Sky Web Portal is manufactured by Soberlink Healthcare, LLC.
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.
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Official Source
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