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)

SmartTouch

K-Number: K163485 · 2017-08-30

ApplicantAdherium (Nz), Ltd.
Decision Date2017-08-30
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SmartTouch is a medical device manufactured by Adherium (Nz), Ltd.. It received FDA 510(k) clearance on 2017-08-30 under approval number K163485. 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 SmartTouch?

SmartTouch is a medical device that received FDA 510(k) clearance on 2017-08-30. It is manufactured by Adherium (Nz), Ltd.. The 510(k) number is K163485.

When was SmartTouch approved by the FDA?

SmartTouch received FDA 510(k) clearance on 2017-08-30, under approval number K163485.

What company makes SmartTouch?

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

What is the FDA product code for SmartTouch?

The FDA product code for SmartTouch is CAF.

Other Devices by Adherium (Nz), Ltd.

K181405Hailie Sensor K180407Smartinhaler 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.

↑