DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1— 510(k) K981378

Substantially Equivalent

Datex-Engstrom, Inc.

FDA 510(k) clearance K981378 for DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1, Substantially Equivalent on 1998-11-03. Applicant: Datex-Engstrom, Inc..

Clearance details

Applicant: Datex-Engstrom, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1998-04-16
Decision date: 1998-11-03
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, 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.