MiniBox +
K-Number: K161295 · 2016-10-21
Decision Date2016-10-21
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
MiniBox + is a medical device manufactured by Pulmone Advanced Medical Devices, Ltd.. It received FDA 510(k) clearance on 2016-10-21 under approval number K161295. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MiniBox +?
MiniBox + is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by Pulmone Advanced Medical Devices, Ltd.. The 510(k) number is K161295.
When was MiniBox + approved by the FDA?
MiniBox + received FDA 510(k) clearance on 2016-10-21, under approval number K161295.
What company makes MiniBox +?
MiniBox + is manufactured by Pulmone Advanced Medical Devices, Ltd..
What is the FDA product code for MiniBox +?
The FDA product code for MiniBox + is BZC.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.