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)

Portable (Ultrasonic) Nebulizer

K-Number: K230379 · 2023-11-27

ApplicantDongguan Simzo Electronic Technology Co., Ltd.
Decision Date2023-11-27
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Portable (Ultrasonic) Nebulizer is a medical device manufactured by Dongguan Simzo Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-27 under approval number K230379. 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 Portable (Ultrasonic) Nebulizer?

Portable (Ultrasonic) Nebulizer is a medical device that received FDA 510(k) clearance on 2023-11-27. It is manufactured by Dongguan Simzo Electronic Technology Co., Ltd.. The 510(k) number is K230379.

When was Portable (Ultrasonic) Nebulizer approved by the FDA?

Portable (Ultrasonic) Nebulizer received FDA 510(k) clearance on 2023-11-27, under approval number K230379.

What company makes Portable (Ultrasonic) Nebulizer?

Portable (Ultrasonic) Nebulizer is manufactured by Dongguan Simzo Electronic Technology Co., Ltd..

What is the FDA product code for Portable (Ultrasonic) Nebulizer?

The FDA product code for Portable (Ultrasonic) Nebulizer is CAF.

Other Devices by Dongguan Simzo Electronic Technology Co., Ltd.

K173048No-contact Forehead Thermometer K211583Infrared Thermometer, Model: HW-1

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.

↑