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)

Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)

K-Number: K243468 · 2025-07-02

ApplicantJoytech Healthcare Co. , Ltd.
Decision Date2025-07-02
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) is a medical device manufactured by Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2025-07-02 under approval number K243468. 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 Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)?

Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by Joytech Healthcare Co. , Ltd.. The 510(k) number is K243468.

When was Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) approved by the FDA?

Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) received FDA 510(k) clearance on 2025-07-02, under approval number K243468.

What company makes Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)?

Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) is manufactured by Joytech Healthcare Co. , Ltd..

What is the FDA product code for Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)?

The FDA product code for Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) is CAF.

Other Devices by Joytech Healthcare Co. , Ltd.

K172989Electric Breast Pump K170666The Wrist-Type Fully Automatic Digital Blood Pressure Monitors K163518Digital Thermometer K181239Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer K181081Infrared Ear Thermometer K173024Non-invasive blood pressure measurement systems

View all 22 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.

↑