INFINITY CNAP SMARTPOD— 510(k) K102968

Substantially Equivalent

Draeger Medical Systems, Inc.

FDA 510(k) clearance K102968 for INFINITY CNAP SMARTPOD, Substantially Equivalent on 2011-02-18. Applicant: Draeger Medical Systems, Inc..

Clearance details

Applicant: Draeger Medical Systems, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2010-10-06
Decision date: 2011-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.