MODIFICATION TO INFINITY EXPLORER— 510(k) K060254

Name: FDA 510(k) clearance K060254
Creator: U.S. Food and Drug Administration
Published: 2006-04-04

Substantially Equivalent

Draeger Medical Systems, Inc.

FDA 510(k) clearance K060254 for MODIFICATION TO INFINITY EXPLORER, Substantially Equivalent on 2006-04-04. Applicant: Draeger Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Draeger Medical Systems, Inc.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2006-02-01
Decision date: 2006-04-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.