Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Smartinhaler

K-Number: K180407 · 2018-07-25

ApplicantAdherium (Nz), Ltd.
Decision Date2018-07-25
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Smartinhaler is a medical device manufactured by Adherium (Nz), Ltd.. It received FDA 510(k) clearance on 2018-07-25 under approval number K180407. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smartinhaler?

Smartinhaler is a medical device that received FDA 510(k) clearance on 2018-07-25. It is manufactured by Adherium (Nz), Ltd.. The 510(k) number is K180407.

When was Smartinhaler approved by the FDA?

Smartinhaler received FDA 510(k) clearance on 2018-07-25, under approval number K180407.

What company makes Smartinhaler?

Smartinhaler is manufactured by Adherium (Nz), Ltd..

What is the FDA product code for Smartinhaler?

The FDA product code for Smartinhaler is CAF.

Other Devices by Adherium (Nz), Ltd.

K163485SmartTouch K181405Hailie Sensor K173310SmartTouch K182638Hailie Sensor K182573Hailie Sensor K211233Hailie Sensor NF0109

View all 10 devices →

Related Devices (Code: CAF)

K161454Propeller Sensor Model 2015-EReciprocal Labs Corporation K153010Hudson RCI AquaPak Sterile Prefilled NebulizersTeleflexmedical, Inc. K152882Propeller SystemReciprocal Labs K152482Propeller Sensor Model 2014-RReciprocal Labs K142541POCKET NEBMicrovaper Devices K170916Portable NebulizerMicrobase Technology Corporation

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.

↑