INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL— 510(k) K033957

Substantially Equivalent

Draeger Medical Systems, Inc.

FDA 510(k) clearance K033957 for INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL, Substantially Equivalent on 2004-05-14. Applicant: Draeger Medical Systems, Inc..

Clearance details

Applicant: Draeger Medical Systems, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2003-12-22
Decision date: 2004-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, 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.