FDA 510(k)

Peak.me

K-Number: K180487 · 2018-10-26

Decision Date2018-10-26

Product CodeBZH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Peak.me is the device name listed in this FDA 510(k) record. The listed applicant is Breathe Me, Ltd.. It received FDA 510(k) clearance on 2018-10-26 under 510(k) 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. The listed applicant is Breathe Me, Ltd.. The 510(k) number is K180487.

When did Peak.me receive FDA 510(k) clearance?

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

Who is the listed applicant for Peak.me?

The FDA 510(k) record lists Breathe Me, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Peak.me?

The FDA product code for Peak.me is BZH.

Related Devices (Code: BZH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife Corporation K252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.K241338Peak Flow MeterChongqing Moffy Innovation Technology Co., Ltd.K232588Aluna 2Knox Medical Diagnostics K230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd.K222810TD-7301 Peak Flow meterGostar Co., Ltd.

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.