FDA 510(k)

MiniBox +

K-Number: K161295 · 2016-10-21

ApplicantPulmone Advanced Medical Devices, Ltd.

Decision Date2016-10-21

Product CodeBZC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MiniBox + is the device name listed in this FDA 510(k) record. The listed applicant is Pulmone Advanced Medical Devices, Ltd.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) 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. The listed applicant is Pulmone Advanced Medical Devices, Ltd.. The 510(k) number is K161295.

When did MiniBox + receive FDA 510(k) clearance?

MiniBox + received FDA 510(k) clearance on 2016-10-21, under 510(k) number K161295.

Who is the listed applicant for MiniBox +?

The FDA 510(k) record lists Pulmone Advanced Medical Devices, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiniBox +?

The FDA product code for MiniBox + is BZC.

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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.