Cleared Traditional

ABPMpro

K231104 · Somnomedics GmbH · Cardiovascular
Nov 2023
Decision
222d
Days
Class 2
Risk

About This 510(k) Submission

K231104 is an FDA 510(k) clearance for the ABPMpro, a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Somnomedics GmbH (Randersacker, DE). The FDA issued a Cleared decision on November 27, 2023, 222 days after receiving the submission on April 19, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K231104 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2023
Decision Date November 27, 2023
Days to Decision 222 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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