M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130— 510(k) K103214

Name: FDA 510(k) clearance K103214
Creator: U.S. Food and Drug Administration
Published: 2010-12-01

Substantially Equivalent

Lifeline Systems, Inc.

FDA 510(k) clearance K103214 for M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130, Substantially Equivalent on 2010-12-01. Applicant: Lifeline Systems, Inc.. Device class: 2.

Clearance details

Applicant: Lifeline Systems, Inc.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2010-11-01
Decision date: 2010-12-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Framingham, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.