ASCOM MOBILE MONITORING GATEWAY (MMG)— 510(k) K111215

Name: FDA 510(k) clearance K111215
Creator: U.S. Food and Drug Administration
Published: 2011-07-05

Substantially Equivalent

Ascom (Sweden) AB

FDA 510(k) clearance K111215 for ASCOM MOBILE MONITORING GATEWAY (MMG), Substantially Equivalent on 2011-07-05. Applicant: Ascom (Sweden) AB. Device class: 2.

Clearance details

Applicant: Ascom (Sweden) AB
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2011-05-02
Decision date: 2011-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goteborg, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code MSX

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K261287 — Digistat Care2026-09-12
K260211 — Dashboard (P007000)2026-08-13
K261367 — Corsano CardioWatch 287-2 System2026-07-26
K253654 — IntelliVue Measurement Rack 6000 (867317)2026-03-30
K243270 — TigerConnect Alarm Management2025-09-30

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K180566 — Unite Connect for Clinical Systems2018-04-03

Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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 →

Recalls naming K111215

K-number listed on FDA's recall record

Z-1638-2016 — Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).Class II·Terminated·Ascom US, INC.·20151210

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111215.

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