INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET— 510(k) K113798

Substantially Equivalent

Draeger Medical Systems, Inc.

FDA 510(k) clearance K113798 for INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET, Substantially Equivalent on 2012-03-22. Applicant: Draeger Medical Systems, Inc..

Clearance details

Applicant: Draeger Medical Systems, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2011-12-23
Decision date: 2012-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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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.