MRI COMPATIBLE MONITOR AND ACCESSORIES— 510(k) K980362

Substantially Equivalent

Datex-Engstrom, Inc.

FDA 510(k) clearance K980362 for MRI COMPATIBLE MONITOR AND ACCESSORIES, Substantially Equivalent on 1998-06-30. Applicant: Datex-Engstrom, Inc..

Clearance details

Applicant: Datex-Engstrom, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1998-01-29
Decision date: 1998-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tewksbury, MA, US

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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.