ELI 380 ELECTROCARDIOGRAPH— 510(k) K142105
Substantially EquivalentMortara Instrument, Inc.
FDA 510(k) clearance K142105 for ELI 380 ELECTROCARDIOGRAPH, Substantially Equivalent on 2014-09-05. Applicant: Mortara Instrument, Inc.. Device class: 2.
Clearance details
- Applicant
- Mortara Instrument, Inc.
- Product code
- Code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Milwaukee, WI, US
Recent devices under product code DPS
view allMore clearances from Mortara Instrument, Inc.
view allAdverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . 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 K142105
K-number listed on FDA's recall record- Z-1013-2023 — Baxter Electrocardiograph, ELI 380 -DCS21
- Z-1483-2021 — ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
- Z-1796-2015 — ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142105.
Data sourced from openFDA. This site is unofficial and independent of the FDA.