MODIFICATION TO ENVOY PATIENT MONITOR— 510(k) K011784

Name: FDA 510(k) clearance K011784
Creator: U.S. Food and Drug Administration
Published: 2001-08-16

Substantially Equivalent

Mennen Medical , Ltd.

FDA 510(k) clearance K011784 for MODIFICATION TO ENVOY PATIENT MONITOR, Substantially Equivalent on 2001-08-16. Applicant: Mennen Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Mennen Medical , Ltd.
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2001-06-08
Decision date: 2001-08-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Rehovot, IL

Download summary PDF View on FDA.gov ↗

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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.