Cleared Traditional

AeviceMD

K223382 · Aevice Health Pte. , Ltd. · Anesthesiology
Jul 2023
Decision
242d
Days
Class 2
Risk

About This 510(k) Submission

K223382 is an FDA 510(k) clearance for the AeviceMD, a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Aevice Health Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on July 7, 2023, 242 days after receiving the submission on November 7, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K223382 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2022
Decision Date July 07, 2023
Days to Decision 242 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DSH — Recorder, Magnetic Tape, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800