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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 the device name listed in this FDA 510(k) record. The listed applicant is Respinova, Ltd.. It received FDA 510(k) clearance on 2021-03-31 under 510(k) 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. The listed applicant is Respinova, Ltd.. The 510(k) number is K203378.

When did Pulsehaler receive FDA 510(k) clearance?

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

Who is the listed applicant for Pulsehaler?

The FDA 510(k) record lists Respinova, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulsehaler?

The FDA product code for Pulsehaler is BWF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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