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FDA 510(k)

eRapid Nebulizer System

K-Number: K223840 · 2023-08-11

ApplicantPari Respiratory Equipment, Inc.
Decision Date2023-08-11
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

eRapid Nebulizer System is a medical device manufactured by Pari Respiratory Equipment, Inc.. It received FDA 510(k) clearance on 2023-08-11 under approval number K223840. 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 eRapid Nebulizer System?

eRapid Nebulizer System is a medical device that received FDA 510(k) clearance on 2023-08-11. It is manufactured by Pari Respiratory Equipment, Inc.. The 510(k) number is K223840.

When was eRapid Nebulizer System approved by the FDA?

eRapid Nebulizer System received FDA 510(k) clearance on 2023-08-11, under approval number K223840.

What company makes eRapid Nebulizer System?

eRapid Nebulizer System is manufactured by Pari Respiratory Equipment, Inc..

What is the FDA product code for eRapid Nebulizer System?

The FDA product code for eRapid Nebulizer System is CAF.

Related Clinical Trials

NCT07531901 Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid NOT_YET_RECRUITING

Other Devices by Pari Respiratory Equipment, Inc.

K150044O-PEP K162785Velox Nebulizer System K191270Proneb Max K251572eRapid with eTrack System

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.

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