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FDA 510(k)

Proneb Max

K-Number: K191270 · 2020-01-23

ApplicantPari Respiratory Equipment, Inc.
Decision Date2020-01-23
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Proneb Max is a medical device manufactured by Pari Respiratory Equipment, Inc.. It received FDA 510(k) clearance on 2020-01-23 under approval number K191270. 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 Proneb Max?

Proneb Max is a medical device that received FDA 510(k) clearance on 2020-01-23. It is manufactured by Pari Respiratory Equipment, Inc.. The 510(k) number is K191270.

When was Proneb Max approved by the FDA?

Proneb Max received FDA 510(k) clearance on 2020-01-23, under approval number K191270.

What company makes Proneb Max?

Proneb Max is manufactured by Pari Respiratory Equipment, Inc..

What is the FDA product code for Proneb Max?

The FDA product code for Proneb Max is CAF.

Other Devices by Pari Respiratory Equipment, Inc.

K150044O-PEP K162785Velox Nebulizer System K223840eRapid Nebulizer System K251572eRapid with eTrack System

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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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