INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor— 510(k) K182868

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K182868 for INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor, Substantially Equivalent on 2019-01-08. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2018-10-12
Decision date: 2019-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

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.