Cleared Traditional

Somfit

K231546 · Compumedics Limited · Neurology
Nov 2023
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K231546 is an FDA 510(k) clearance for the Somfit, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Compumedics Limited (Abbotsford, AU). The FDA issued a Cleared decision on November 30, 2023, 184 days after receiving the submission on May 30, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K231546 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2023
Decision Date November 30, 2023
Days to Decision 184 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375