DeviceClearance

K981378

Substantially Equivalent

DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1

Applicant
Datex-Engstrom, Inc.
Product code
DRT
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tewksburt, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT
Death
4
Total
4

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 →

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