Cleared Traditional

AcuPebble SA

K210480 · Acurable Limited · Anesthesiology
Jul 2021
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K210480 is an FDA 510(k) clearance for the AcuPebble SA, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Acurable Limited (London, GB). The FDA issued a Cleared decision on July 6, 2021, 137 days after receiving the submission on February 19, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K210480 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2021
Decision Date July 06, 2021
Days to Decision 137 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