SENSOMETRICS SOFTWARE— 510(k) K101133

Name: FDA 510(k) clearance K101133
Creator: U.S. Food and Drug Administration
Published: 2010-11-18

Substantially Equivalent

Dpcom AS

FDA 510(k) clearance K101133 for SENSOMETRICS SOFTWARE, Substantially Equivalent on 2010-11-18. Applicant: Dpcom AS. Device class: 2.

Clearance details

Applicant: Dpcom AS
Product code: Code GWM
Device class: Class 2
Regulation: 21 CFR 882.1620
Advisory panel: Neurology
Date received: 2010-04-22
Decision date: 2010-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ne, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWM

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K252241 — Pressio 3 Multi-parameter Neuromonitoring System2026-04-10
K250285 — NEUROVENT-P (092946-003) +15 more2025-08-29
K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000)2024-07-18
K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)2024-02-04
K201989 — B4C System2021-10-08

Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.