Cleared Traditional

AcuPebble OX100

K222950 · Acurable Limited · Anesthesiology
Feb 2023
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K222950 is an FDA 510(k) clearance for the AcuPebble OX100, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Acurable Limited (London, GB). The FDA issued a Cleared decision on February 3, 2023, 129 days after receiving the submission on September 27, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K222950 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2022
Decision Date February 03, 2023
Days to Decision 129 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

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