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)

Pulsehaler

K-Number: K203378 · 2021-03-31

ApplicantRespinova, Ltd.
Decision Date2021-03-31
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Pulsehaler is a medical device manufactured by Respinova, Ltd.. It received FDA 510(k) clearance on 2021-03-31 under approval number K203378. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pulsehaler?

Pulsehaler is a medical device that received FDA 510(k) clearance on 2021-03-31. It is manufactured by Respinova, Ltd.. The 510(k) number is K203378.

When was Pulsehaler approved by the FDA?

Pulsehaler received FDA 510(k) clearance on 2021-03-31, under approval number K203378.

What company makes Pulsehaler?

Pulsehaler is manufactured by Respinova, Ltd..

What is the FDA product code for Pulsehaler?

The FDA product code for Pulsehaler is BWF.

Related Devices (Code: BWF)

K160636iPEP System and vPEPD R Burton Healthcare, LLC K150044O-PEPPari Respiratory Equipment, Inc. K153441VibraPEPMedica Holdings, LLC K172388VPOD ITPRAdvanced Circulatory System, A Wholly Owned Subsidiary OF K160837MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAMMedinet Srl K163091VibraPEPMedica Holdings, LLC

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.

↑