Pulsehaler— 510(k) K203378

Substantially Equivalent

Respinova, Ltd.

FDA 510(k) clearance K203378 for Pulsehaler, Substantially Equivalent on 2021-03-31. Applicant: Respinova, Ltd.. Device class: 2.

Clearance details

Applicant: Respinova, Ltd.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2020-11-17
Decision date: 2021-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herzliya, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.