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FDA 510(k)

Peak.me

K-Number: K180487 · 2018-10-26

ApplicantBreathe Me, Ltd.
Decision Date2018-10-26
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Peak.me is a medical device manufactured by Breathe Me, Ltd.. It received FDA 510(k) clearance on 2018-10-26 under approval number K180487. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Peak.me?

Peak.me is a medical device that received FDA 510(k) clearance on 2018-10-26. It is manufactured by Breathe Me, Ltd.. The 510(k) number is K180487.

When was Peak.me approved by the FDA?

Peak.me received FDA 510(k) clearance on 2018-10-26, under approval number K180487.

What company makes Peak.me?

Peak.me is manufactured by Breathe Me, Ltd..

What is the FDA product code for Peak.me?

The FDA product code for Peak.me is BZH.

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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.

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