ENVOY PATIENT MONITOR— 510(k) K001120

Substantially Equivalent

Mennen Medical , Ltd.

FDA 510(k) clearance K001120 for ENVOY PATIENT MONITOR, Substantially Equivalent on 2001-05-08. Applicant: Mennen Medical , Ltd..

Clearance details

Applicant: Mennen Medical , Ltd.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2000-04-07
Decision date: 2001-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.