MOBILEECG SYSTEM— 510(k) K103427

Substantially Equivalent

Memtec Corp.

FDA 510(k) clearance K103427 for MOBILEECG SYSTEM, Substantially Equivalent on 2011-03-24. Applicant: Memtec Corp..

Clearance details

Applicant: Memtec Corp.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2010-11-22
Decision date: 2011-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salem, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.