Cleared Traditional

Pulsehaler

K203378 · Respinova, Ltd. · Anesthesiology
Mar 2021
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K203378 is an FDA 510(k) clearance for the Pulsehaler, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Respinova, Ltd. (Herzliya, IL). The FDA issued a Cleared decision on March 31, 2021, 134 days after receiving the submission on November 17, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K203378 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2020
Decision Date March 31, 2021
Days to Decision 134 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BWF — Spirometer, Therapeutic (incentive)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5690