DeviceClearance

ELI 280 ELECTROCARDIOGRAPH— 510(k) K122073

Substantially Equivalent

Mortara Instrument, Inc.

FDA 510(k) clearance K122073 for ELI 280 ELECTROCARDIOGRAPH, Substantially Equivalent on 2012-08-02. 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
Download summary PDFView on FDA.gov ↗

Recent devices under product code DPS

view all

More clearances from Mortara Instrument, Inc.

view all

Adverse 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 K122073

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122073.

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