Infinity Delta, Infinity Delta XL, Infinity Kappa— 510(k) K152407

Substantially Equivalent

Draeger Medical Sytems, Inc.

FDA 510(k) clearance K152407 for Infinity Delta, Infinity Delta XL, Infinity Kappa, Substantially Equivalent on 2015-09-23. Applicant: Draeger Medical Sytems, Inc..

Clearance details

Applicant: Draeger Medical Sytems, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2015-08-25
Decision date: 2015-09-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.