AMBULATORY CARDIAC MONITOR— 510(k) K896064

Substantially Equivalent

Monitech, Inc.

FDA 510(k) clearance K896064 for AMBULATORY CARDIAC MONITOR, Substantially Equivalent on 1990-01-26. Applicant: Monitech, Inc..

Clearance details

Applicant: Monitech, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1989-10-18
Decision date: 1990-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Duluth, GA, 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.